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Neural Bases of Cognitive Rehabilitation for Brain Injury

Primary Purpose

Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goal-oriented attentional self-regulation
Brain Health Education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring executive dysfunction, brain injury, attention, rehabilitation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).

Exclusion Criteria:

  • Severely apathetic/abulic
  • aphasic
  • or other reasons for patients being unable or unwilling to participate with the training tasks
  • severe cognitive dysfunction
  • history of neurodevelopmental abnormalities
  • ongoing illicit drug or alcohol abuse (AUDIT>8)
  • severe depression as measured by Beck Depression Inventory (>29)
  • severe PTSD precluding participation in research activities (such as group training or MRI scanning)
  • There will be no restriction in regard to gender, race and socioeconomic status.

Sites / Locations

  • Martinez Outpatient Clinic and Community Living Center, Martinez, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Goal-oriented attentional self-regulation training

Brain Health Education

Arm Description

Goal-oriented attentional self-regulation training (GOALS).

Brain Health Education (EDU)

Outcomes

Primary Outcome Measures

Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.

Secondary Outcome Measures

Functional Evaluations: Change From Baseline on the Goal Processing Scale
Observed measures of functional performance on complex tasks were assessed for the GOALS and Brain Health Education study. The overall composite score comprises scores for planning, initiation, self-monitoring, maintenance of attention, sequencing and switching, divergent thinking, execution, learning and memory. Scores range from 1-10. Changes were calculated from pre-to post-training, and higher scores indicate improvement in functioning.

Full Information

First Posted
May 7, 2010
Last Updated
June 12, 2019
Sponsor
VA Office of Research and Development
Collaborators
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT01120756
Brief Title
Neural Bases of Cognitive Rehabilitation for Brain Injury
Official Title
Neural Bases of Cognitive Rehabilitation for Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2011 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
December 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of California, Berkeley

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.
Detailed Description
Brain injury often results in a disruption of attention regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. More intervention options are needed. We set out to test different possible interventions. Individuals with traumatic brain injury (TBI) and chronic executive control dysfunction participate in interventions, with pre- and post-intervention measurements of cognitive functioning. Training in Goal-oriented attentional self-regulation (GOALS) was administered in comparison to Brain Health Education (EDU). GOALS is designed to train attention regulation skills along with meta-cognitive strategies for goal management, with a emphasis on application to participant-selected projects. This is a group-based intervention. Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning. This is a group-based intervention matched to the GOALS intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
executive dysfunction, brain injury, attention, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal-oriented attentional self-regulation training
Arm Type
Experimental
Arm Description
Goal-oriented attentional self-regulation training (GOALS).
Arm Title
Brain Health Education
Arm Type
Active Comparator
Arm Description
Brain Health Education (EDU)
Intervention Type
Behavioral
Intervention Name(s)
Goal-oriented attentional self-regulation
Intervention Description
This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Education
Intervention Description
Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
Primary Outcome Measure Information:
Title
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
Description
We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.
Time Frame
Baseline, Within 2-3 weeks Post-intervention
Secondary Outcome Measure Information:
Title
Functional Evaluations: Change From Baseline on the Goal Processing Scale
Description
Observed measures of functional performance on complex tasks were assessed for the GOALS and Brain Health Education study. The overall composite score comprises scores for planning, initiation, self-monitoring, maintenance of attention, sequencing and switching, divergent thinking, execution, learning and memory. Scores range from 1-10. Changes were calculated from pre-to post-training, and higher scores indicate improvement in functioning.
Time Frame
Baseline, 2-3 Weeks Post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory). Exclusion Criteria: Severely apathetic/abulic aphasic or other reasons for patients being unable or unwilling to participate with the training tasks severe cognitive dysfunction history of neurodevelopmental abnormalities ongoing illicit drug or alcohol abuse (AUDIT>8) severe depression as measured by Beck Depression Inventory (>29) severe PTSD precluding participation in research activities (such as group training or MRI scanning) There will be no restriction in regard to gender, race and socioeconomic status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Chen, MD MA
Organizational Affiliation
Martinez Outpatient Clinic, Martinez, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29717652
Citation
Novakovic-Agopian T, Kornblith E, Abrams G, Burciaga-Rosales J, Loya F, D'Esposito M, Chen AJW. Training in Goal-Oriented Attention Self-Regulation Improves Executive Functioning in Veterans with Chronic Traumatic Brain Injury. J Neurotrauma. 2018 Dec 1;35(23):2784-2795. doi: 10.1089/neu.2017.5529. Epub 2018 Jul 23.
Results Reference
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Neural Bases of Cognitive Rehabilitation for Brain Injury

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