Neural Bases of Cognitive Rehabilitation for Brain Injury

NCT01120756 | Completed Results DMC

• 1 other identifier: B7467-I
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury

Keywords

executive dysfunction; brain injury; attention; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Within 2-3 weeks Post-intervention

Secondary Outcomes (1)

• Functional Evaluations: Change From Baseline on the Goal Processing Scale

  Baseline, 2-3 Weeks Post-intervention

Study Arms (2)

Goal-oriented attentional self-regulation training

EXPERIMENTAL

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

Behavioral: Goal-oriented attentional self-regulation

Brain Health Education

ACTIVE COMPARATOR

Brain Health Education (EDU)

Behavioral: Brain Health Education

Interventions

Goal-oriented attentional self-regulation BEHAVIORAL

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.

Goal-oriented attentional self-regulation training

Brain Health Education BEHAVIORAL

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.

Brain Health Education

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, Berkeley: collaborator

Study Sites (1)

Martinez Outpatient Clinic and Community Living Center, Martinez, CA

Martinez, California, 94553, United States

Location

Related Publications (1)

• 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.

  PMID: 29717652 RESULT

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Anthony Chen, MD
• Organization: VA Northern California

anthony.chen@va.gov

925-372-2000

Study Officials

• Anthony Chen, MD MA

  Martinez Outpatient Clinic, Martinez, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: October 1, 2011
• Primary Completion: May 30, 2018
• Study Completion: December 29, 2018
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)