Cognitive Rehabilitation and Brain Activity of Attention Control in TBI

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• Status: Withdrawn
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Behavioral: Direct-attention training using web-based BrainHQ; Behavioral: Goal Management Training (GMT)

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Timed Instrumental Activities of Daily Living (TIADL)	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)	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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)	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Mindful Attention Awareness Scale-Lapses Only (MAAS-LO)	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)	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)	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)	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)	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)	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)	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)	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

Outcome Measure	Measure Description	Time Frame
Ruff 2 & 7 Selective Attention Task (RSAT)	Psychometric validation/measurement of participant's subjective complaint of attention disturbance	Eligibility screening (Pretreatment)
Reliable Digit Span (RDS)	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)	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)	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

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: William M Perlstein, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Attention; Event-related potentials; Cognitive rehabilitation; Independent activities of daily living
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID 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