Cognitive Rehabilitation and Brain Activity of Attention Control in TBI

February 3, 2022 updated by: VA Office of Research and Development

Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI

The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Attention impairment is ubiquitous in TBI survivors. This is a devastating impairment because attention is the backbone of cognitive systems. Attention is requisite for other cognitive processes that are vital to everyday functioning such as memory, problem solving, language skills, and the cognitive control of behavior. Studies of attention training have shown improved attention on laboratory measures, but limited translation to real-world tasks. Notably, these previously-tested rehabilitation approaches have not included training in the very cognitive processes needed for translation of training to everyday tasks which include internal verbalization and self-monitoring, also called metacognitive strategies. One training method for metacognitive strategies has shown promise, but is lacking in basic attention training. Rehabilitation specialists have recently argued for a rehabilitation approach wherein both basic foundational attention and metacognitive strategies should be synergistically combined. Consequently, the investigators will test an innovative combination of direct-attention training and metacognitive training for which the other compensates disadvantages of each. Because of the promise of each type of training separately, and the potential additive effects of the combination, it is critical to test this combined attention and metacognitive training in Veteran survivors of chronic moderate-to-severe traumatic brain injury (TBI). The investigators will address the following two specific aims: the investigators propose to conduct a pilot study to examine cognitive rehabilitation therapy (CRT) effects in a group of Veterans with chronic moderate to severe TBI (m/sTBI), focused on remediating attention-control impairments using both direct-attention and metacognitive-strategy training approaches in a AB/BA crossover design with 1-month follow-up to address the following two specific aims: 1) Test treatment response to combined direct-attention and metacognitive-strategy training in Veterans with chronic m/sTBI; and 2) identify mechanisms and biomarkers of rehabilitation-related neuroplasticity. Under the first aim the investigators will test for effects of combined direct-attention and metacognitive-strategy training on measures of complex functional activities and neurocognitive tests of attention-control functions. Under the second aim, the investigators will test effects of the their CRT approach on behavioral and brain activity while participants perform a well-validated attentional task that probes the function of three dissociable attentional systems. The approach is innovative because it combines a theoretically motivated and novel approach to address a significant source of disability in Veteran survivors of TBI. The proposed research is significant because findings will form the foundation for a larger-scale trial to enable us to determine the durability of gains and the functional impact of treatment on Veteran's real world activities and to more positively shape healthcare for our Veterans who are suffering from TBI. Outcome measures will include standardized tests of neurocognitive functioning such as attention and other cognitive skills, measures of self care, ability to live independently, social role participation, life satisfaction, TBI-related quality of life, mood/anxiety, and attention-related scalp-recorded brain event-related potentials (ERPs, derived from electroencephalography).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System, Gainesville, FL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OEF/OIF/OND Veterans with moderate or severe TBI as described by DOD/VA common definition.
  • Self-report of attentional problems, confirmed with psychometric testing.
  • Ruff 2 & 7 selective attention task score <= 1.5 standard deviations from demographically-matched norms.
  • Able to participate in study at 12-60 months post injury without contraindications.
  • Age 21-55 years.
  • Willingness to be randomized and to participate in treatment procedures.
  • Capacity to visit the laboratory for repeated treatment and testing sessions.
  • Access to internet-enabled home computer.
  • English as Native language.
  • Adequate reading comprehension to allow completion of study-related questionnaires.
  • Reliable digit span (RDS) score > 7.

Exclusion Criteria:

  • Pre-existing neurological disorder associated with cerebral dysfunction (e.g., stroke, history of epilepsy or chronic seizure disorder).
  • Current alcohol or drug use/dependence.
  • Pre-existing severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or history of psychiatric diagnosis sufficiently severe to have resulted in inpatient hospitalization.
  • Current suicidal or homicidal ideation.
  • Reported involvement in current litigation.
  • Reported history of pre-injury learning disability.
  • Not competent to provide written informed consent (i.e., not able to demonstrate understanding or expectations of study and potential risks of participation).
  • Does not fully understand the nature of the study and requirements of participation.
  • Does not understand task instructions.
  • Validity testing score on RDS <= 7.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Direct-Metacognitive
Direct attention training followed by metacognitive strategy training
Behavioral: Direct-attention training using web-based BrainHQ
BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame."
Behavioral: Goal Management Training (GMT)
A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.
Experimental: Metacognitive-Direct
Metacognitive strategy training followed by direct-attention training
Behavioral: Direct-attention training using web-based BrainHQ
BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: "Divided attention," "Target tracker," "Double Decision," "Mixed Signals," and "Freeze Frame."
Behavioral: Goal Management Training (GMT)
A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Timed Instrumental Activities of Daily Living (TIADL)
Time Frame: Baseline TIADL Reaction Time assessed pretreatment
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Baseline TIADL Reaction Time assessed pretreatment
Timed Instrumental Activities of Daily Living (TIADL)
Time Frame: Change from Baseline in TIADL Reaction Time assessed at 8 weeks
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Change from Baseline in TIADL Reaction Time assessed at 8 weeks
Timed Instrumental Activities of Daily Living (TIADL)
Time Frame: Change from Baseline in TIADL Reaction Time assessed at 12 weeks (1-month post treatment)
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Change from Baseline in TIADL Reaction Time assessed at 12 weeks (1-month post treatment)
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
Time Frame: Change from Baseline in TIADL Accuracy assessed at 4 weeks
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Change from Baseline in TIADL Accuracy assessed at 4 weeks
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
Time Frame: Change from Baseline in TIADL Accuracy assessed at 8 weeks
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Change from Baseline in TIADL Accuracy assessed at 8 weeks
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy
Time Frame: Change from Baseline in TIADL Accuracy assessed at 12 weeks (1 month post treatment)
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Change from Baseline in TIADL Accuracy assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time Frame: Change from Baseline in MPAI-4 Ability Score assessed at 4 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Ability Score assessed at 4 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time Frame: Change from Baseline in MPAI-4 Ability Score assessed at 8 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Ability Score assessed at 8 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time Frame: Change from Baseline in MPAI-4 Ability Score assessed at 12 weeks (1 month post treatment)
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Ability Score assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time Frame: Change from Baseline in MPAI-4 Adjustment Score assessed at 4 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Adjustment Score assessed at 4 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time Frame: Change from Baseline in MPAI-4 Adjustment Score assessed at 8 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Adjustment Score assessed at 8 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time Frame: Change from Baseline in MPAI-4 Adjustment Score assessed at 12 weeks (1 month post treatment)
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Adjustment Score assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time Frame: Change from Baseline in MPAI-4 Participation Score assessed at 4 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Participation Score assessed at 4 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time Frame: Change from Baseline in MPAI-4 Participation Score assessed at 8 weeks
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Participation Score assessed at 8 weeks
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time Frame: Change from Baseline in MPAI-4 Participation Score assessed at 12 weeks (1 month post treatment)
Assesses global outcome, including ability, adjustment and community participation indices.
Change from Baseline in MPAI-4 Participation Score assessed at 12 weeks (1 month post treatment)
Timed Instrumental Activities of Daily Living (TIADL) - Reaction Time score
Time Frame: Baseline (pretreatment) on TIADL - Reaction Time score
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Baseline (pretreatment) on TIADL - Reaction Time score
Timed Instrumental Activities of Daily Living (TIADL) - Accuracy score
Time Frame: Baseline (pretreatment) on TIADL - Accuracy score
The TIADL is a timed, performance-based measure of everyday cognition/instrumental activities of daily living (IADLs) in which participants are presented with common everyday stimuli (e.g., medication labels, transportation schedules, cake-mix ingredients, phone book) and asked to answer questions. The dependent variables are the number of accurate responses and response speed to each accurate item is recorded.
Baseline (pretreatment) on TIADL - Accuracy score
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
Time Frame: Baseline (pretreatment) MPAI-4 Adjustment score
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Baseline (pretreatment) MPAI-4 Adjustment score
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4)
Time Frame: Baseline (pretreatment) MPAI-4 Participation score
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Baseline (pretreatment) MPAI-4 Participation score
Attention Network Test (ANT) Alerting Reaction Time score
Time Frame: Change from Baseline in Altering Reaction Time Score assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Altering Reaction Time Score assessed at 4 weeks
Attention Network Test (ANT) Alerting Reaction Time score
Time Frame: Change from Baseline in Altering Reaction Time Score assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Altering Reaction Time Score assessed at 8 weeks
Attention Network Test (ANT) Alerting Reaction Time score
Time Frame: Change from Baseline in Altering Reaction Time Score assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Altering Reaction Time Score assessed at 12 weeks (1 month post treatment)
Attention Network Test (ANT) Orient Reaction Time score
Time Frame: Baseline (pretreatment) Orienting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline (pretreatment) Orienting Reaction Time score
Attention Network Test (ANT) Orienting Reaction Time score
Time Frame: Change from Baseline in Orienting Reaction Time Score assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Orienting Reaction Time Score assessed at 4 weeks
Attention Network Test (ANT) Orienting Reaction Time score
Time Frame: Change from Baseline in Orienting Reaction Time Score assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Orienting Reaction Time Score assessed at 8 weeks
Attention Network Test (ANT) Orienting Reaction Time score
Time Frame: Change from Baseline in Orienting Reaction Time Score assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Orienting Reaction Time Score assessed at 12 weeks (1 month post treatment)
Attention Network Test (ANT) Executive-Control Reaction Time score
Time Frame: Baseline (pretreatment) Executive-Control Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline (pretreatment) Executive-Control Reaction Time score
Attention Network Test (ANT) Executive-Control Reaction Time score
Time Frame: Change from Baseline in Executive-Control Reaction Time Score assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Executive-Control Reaction Time Score assessed at 4 weeks
Attention Network Test (ANT) Executive-Control Reaction Time score
Time Frame: Change from Baseline in Executive-Control Reaction Time Score assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Executive-Control Reaction Time Score assessed at 8 weeks
Attention Network Test (ANT) Executive-Control Reaction Time score
Time Frame: Change from Baseline in Executive-Control Reaction Time Score assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in Executive-Control Reaction Time Score assessed at 12 weeks (1 month post treatment)
Attention Network Test (ANT) Alerting Reaction Time score
Time Frame: Baseline (pretreatment) Alerting Reaction Time score
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline (pretreatment) Alerting Reaction Time score
ANT ERP (N1) Alerting Amplitude
Time Frame: Baseline ANT ERP (N1) Alerting Amplitude assessed pretreatment
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline ANT ERP (N1) Alerting Amplitude assessed pretreatment
ANT ERP (N1) Alerting Amplitude
Time Frame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 4 weeks
ANT ERP (N1) Alerting Amplitude
Time Frame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 8 weeks
ANT ERP (N1) Alerting Amplitude
Time Frame: Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in ANT ERP (N1) Alerting Amplitude assessed at 12 weeks (1 month post treatment)
ANT ERP (N1) Orienting Amplitude
Time Frame: Baseline ANT ERP (N1) Orienting Amplitude assessed pretreatment
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline ANT ERP (N1) Orienting Amplitude assessed pretreatment
ANT ERP (N1) Orienting Amplitude
Time Frame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 4 weeks
ANT ERP (N1) Orienting Amplitude
Time Frame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 8 weeks
ANT ERP (N1) Orienting Amplitude
Time Frame: Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Change from Baseline in ANT ERP (N1) Orienting Amplitude assessed at 12 weeks (1 month post treatment)
ANT ERP (P3) Executive Amplitude
Time Frame: Baseline ANT ERP (P3) Executive Amplitude assessed pretreatment
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline ANT ERP (P3) Executive Amplitude assessed pretreatment
ANT ERP (P3) Executive Amplitude
Time Frame: Baseline ANT ERP (P3) Executive Amplitude assessed at 4 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline ANT ERP (P3) Executive Amplitude assessed at 4 weeks
ANT ERP (P3) Executive Amplitude
Time Frame: Baseline ANT ERP (P3) Executive Amplitude assessed at 8 weeks
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline ANT ERP (P3) Executive Amplitude assessed at 8 weeks
ANT ERP (P3) Executive Amplitude
Time Frame: Baseline ANT ERP (P3) Executive Amplitude assessed at 12 weeks (1 month post treatment)
The ANT combines a covert cueing paradigm with a classic flanker task to behaviorally probe independent but interactive components of attention in a single experimental paradigm. Scalp-recorded electroencephalography (EEG) will be acquired from 64 sensors while participants perform the ANT to derive event-related potentials (ERPs) reflecting alerting, orienting, and executive-control components of attention and enable probing of brain plasticity associated with attention rehabilitation.
Baseline ANT ERP (P3) Executive Amplitude assessed at 12 weeks (1 month post treatment)
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Ability Score
Time Frame: Baseline MPAI-4 Ability Score assessed pretreatment
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Baseline MPAI-4 Ability Score assessed pretreatment
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Adjustment Score
Time Frame: Baseline MPAI-4 Adjustment Score assessed pretreatment
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Baseline MPAI-4 Adjustment Score assessed pretreatment
Mayo-Portland Adaptability Inventory, 4th edition (MPAI-4) - Participation Score
Time Frame: Baseline MPAI-4 Participation Score assessed pretreatment
Assesses global outcome, including ability, adjustment and community participation indices. The MPAI-4 is a 35-item questionnaire-based inventory that will be completed study staff and TBI survivors. It offers three subscales (Ability, Adjustment, and Participation) and has well-documented psychometric properties. MPAI-4 items represent the range of physical, cognitive, emotional, behavioral, and societal problems that TBI survivors often encounter; it also assess major obstacles to community integration.
Baseline MPAI-4 Participation Score assessed pretreatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time Frame: Change from Baseline in MAAS-LO Score assessed at 4 weeks
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Change from Baseline in MAAS-LO Score assessed at 4 weeks
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time Frame: Change from Baseline in MAAS-LO Score assessed at 8 weeks
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Change from Baseline in MAAS-LO Score assessed at 8 weeks
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time Frame: Change from Baseline in MAAS-LO Score assessed at 12 weeks (1 month post treatment)
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Change from Baseline in MAAS-LO Score assessed at 12 weeks (1 month post treatment)
Satisfaction with Life Scale (SWLS)
Time Frame: Baseline SWLS Score assessed pretreatment
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Baseline SWLS Score assessed pretreatment
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)
Time Frame: Baseline (pretreatment) on MAAS-LO
The MAAS-LO is a 12-item 6-point Likert-type scale designed to measure everyday attentional lapses (infrequent to very frequent).
Baseline (pretreatment) on MAAS-LO
Satisfaction with Life Scale (SWLS)
Time Frame: Change from Baseline in SWLS Score assessed at 4 weeks
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Change from Baseline in SWLS Score assessed at 4 weeks
Satisfaction with Life Scale (SWLS)
Time Frame: Change from Baseline in SWLS Score assessed at 8 weeks
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Change from Baseline in SWLS Score assessed at 8 weeks
Satisfaction with Life Scale (SWLS)
Time Frame: Change from Baseline in SWLS Score assessed at 12 weeks (1 month post treatment)
The SWLS assesses patient's perceived satisfaction with life. It is a 5-item 7-point Likert-type scale with a range from "strongly disagree" to "strongly agree." The total score is used as a measure of satisfaction with life.
Change from Baseline in SWLS Score assessed at 12 weeks (1 month post treatment)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ruff 2 & 7 Selective Attention Task (RSAT)
Time Frame: Eligibility screening (Pretreatment)
Psychometric validation/measurement of participant's subjective complaint of attention disturbance
Eligibility screening (Pretreatment)
Reliable Digit Span (RDS)
Time Frame: Eligibility screening (Pretreatment)
The Reliable Digit Span (RDS) test, scored from the forward and backward digit span from the Wechsler Adult Intelligence Scale version 4 (WAIS-IV), will be used to determine the potential presence of suboptimal effort; cutoff for the RDS will be a score 7.
Eligibility screening (Pretreatment)
Mental Health Screening Form 3rd edition (MHSF-III)
Time Frame: Eligibility screening (Pretreatment)
The MHSF-III is a structured interview that will be used to screen for the presence of exclusionary major psychopathology.
Eligibility screening (Pretreatment)
Wide Range Achievement Test, 4th edition (WRAT-4; word-reading subtest)
Time Frame: Group matching (Pretreatment)
The word-reading subtest of the WRAT-4 will administered to obtain a measure of estimated premorbid cognitive functioning, and groups will be matched, on average, for scores on this test.
Group matching (Pretreatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William M Perlstein, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N1920-P
  • I21RX001920-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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