Remediation of Spatial Neglect Trial (RESPONSE)

July 2, 2020 updated by: Posit Science Corporation

RESPONSE: Remediation of Spatial Neglect Trial

Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. This is due to the fact that attention is a necessary component of more complex cognitive functions such as learning & memory, multi-tasking and problem solving. In many cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with acquired brain injury.

Study Overview

Status

Status

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

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

Following consent, participants will engage in an assessment process to determine eligibility. Once eligibility is confirmed, participants will be scheduled for another assessment session to determine current level of cognitive function. This process consists of paper-pencil surveys and computerized tests. Following the assessment process, participants will engage in an Internet browser-delivered training sessions conducted on any internet-accessible computer. The computerized training sessions can be done up to 7 times a week (once a day) or at participant's convenience (we recommend 5 times a week). Following the completion of training, the participant's cognitive function will be re-assessed and again after 3-month no-contact period. Participation is voluntary and participants may withdraw from the study at any time.

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

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

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
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of an acquired brain injury (which may be in the form of a stroke or brain tumor removal) and
  • Evidence of deficit on at least 2 out of 4 assessment measures of Spatial Neglect: Mesulam Cancelation task (ages 50 and younger > 0 omissions; 51-80 > 4 omissions), Dual task (>19% difference in accuracy for right - left target trials), Tone Counting task (< 94% total accuracy), or Landmark task (deviation from objective center as determined by the 95% confidence interval, with neglect indicated with 'Y' and no neglect with 'N' following completion of task).
  • Must be at least 3 months out from their most recent acquired brain injury, stroke, or brain tumor removal
  • Fluent English speakers
  • Adequate sensorimotor capacity to participate in the trial, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse

Exclusion Criteria:

  • A conjunction of prior acquired brain injury and score >8 on Blessed Scale - Short Form
  • Diagnosis of severe depression (a score of >29 on Beck Depression Inventory (BDI-II)
  • Diagnosis of chronic psychiatric disorders with associated cognitive impairments, eg. Schizophrenia
  • Diagnosis of illness, condition or treatment with known cognitive consequences, eg. chemotherapy
  • Active Suicidal Ideation with Specific Plan and Intent or any suicide-related behaviors within 2 months of consent
  • A current or significant past history of substance abuse
  • Difficulty completing assessments and/or comprehending requirements of trial
  • Enrollment in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device or behavioral treatment that could affect the outcome of this study
  • Complete primary visual field deficit, score of 3 on NIH Stroke Scale - Visual Field Subscale

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: Parallel Assignment
  • Masking: Quadruple

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: Experimental Treatment
Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
Other: Computerized Plasticity-based Adaptive Cognitive Training
Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
Active Comparator: Active Comparator
Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
Other: Commercially available computerized training
Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.

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
Performance on Posner Cueing Task
Time Frame: At 3 months
Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention.
At 3 months

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
Change in Spatial Cognition (Multiple scores are aggregated to arrive at a single composite score)
Time Frame: At 3 months and at 6 months

Between-group magnitude of change in composite score with the measure constructed from Greyscales Task (perceptual bias score) and Spatial Working Memory Task (percent accuracy for targets).

The composite is composed of the individual measures combined as follows:

i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1).

ii. Compute the average of all z-scores to create a single score for the composite measure.
At 3 months and at 6 months
Change in Cognitive Performance (Multiple scores are aggregated to arrive at a single composite score)
Time Frame: At 3 months and at 6 months

Between-group magnitude of change in composite score with the measure constructed from Delis-Kaplan Executive Function System Verbal Fluency (Letter Fluency, raw scores; Category Fluency total, raw scores; Category Switching total, raw scores; Category Switching, switching Accuracy total, raw scores), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span total (sum of forward, backward, sequencing raw scores), WAIS-IV Digit Span (Forward total, raw scores; Backward total, raw scores; Sequencing total, raw scores), and Gradual Continuous Performance Task (percent accuracy for targets and standard deviation (SD) of average reaction time for non-targets).

The composite is composed of the individual measures combined as follows:

i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a SD of 1).

ii. Compute the average of all z-scores to create a single score for the composite measure.
At 3 months and at 6 months
Change in Functional Ability (Multiple scores are aggregated to arrive at a single composite score)
Time Frame: At 3 months and at 6 months

Between-group magnitude of change in composite score with the measure constructed from Catherine Bergego Scale total (raw score) and Barthel Index total (raw score).

The composite is composed of the individual measures combined as follows:

i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1).

ii. Compute the average of all z-scores to create a single score for the composite measure.
At 3 months and at 6 months
Change in Quality of Life (Multiple scores are aggregated to arrive at a single composite score)
Time Frame: At 3 months and at 6 months

Between-group magnitude of change in composite score with the measure constructed from SF-12v2 Health Survey Physical and Mental Component Scores.

The composite is composed of the individual measures combined as follows:

i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1).

ii. Compute the average of all z-scores to create a single score for the composite measure.
At 3 months and at 6 months
Change in Quality of Sleep: Pittsburgh Sleep Quality Index (Multiple scores are aggregated to arrive at a single composite score)
Time Frame: At 3 months and at 6 months

Between-group magnitude of change in composite score with the measure constructed from Pittsburgh Sleep Quality Index (PSQI, sum of component scores), PSQI Sleep Efficiency (raw score), and PSQI Component scores.

The composite is composed of the individual measures combined as follows:

i. For each included variable convert the distribution of raw scores in the Intent-to-Treat population at baseline to z-scores (with a mean of 0 and a standard deviation of 1).

ii. Compute the average of all z-scores to create a single score for the composite measure.
At 3 months and at 6 months
Performance on Posner Cueing Task
Time Frame: At 6 months
Between-group magnitude of change in reaction time (RT) for RT detecting targets appearing on the left side of the display minus the RT for detecting targets appearing on the right side of the display as measured by Posner Cueing Task. Positive reaction time difference scores indicate a rightward bias; whereas, negative reaction time difference scores indicate a leftward bias in spatial attention.
At 6 months

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.
Posit Science Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Washington University School of Medicine
Spaulding Rehabilitation Hospital
VA Boston Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
July 1, 2013

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.
March 1, 2017

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.
March 1, 2017

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 16, 2013

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 17, 2013

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 18, 2013

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.
July 7, 2020

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.
July 2, 2020

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.
July 1, 2020

More Information

Terms related to this study

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.
  • PSC-1004-13

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.

Clinical Trials on Stroke

Clinical Trials on Computerized Plasticity-based Adaptive Cognitive Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings