Remotely Deployed TBI Study

NCT01882244 | Unknown

• 1 other identifier: RD2013-04-17
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

Injury to the brain can change the core of a person's being, affecting brain functions necessary to accomplish important goals in a complex world. Deficits in attention, working memory, and other aspects of goal-directed cognition affect a broad range of pursuits in everyday life, and are among the most prevalent and long-lasting consequences of brain injuries. The objective of this research is to develop remotely deployed training tools that target the most common, persistent and debilitating cognitive functions affected by traumatic brain injury (TBI); test the potential effects of the intervention and compare these effects to an active comparison intervention; and determine the neurocognitive and functional effects of computer-assisted remote training.

Conditions

Brain Injury

Keywords

traumatic brain injury; cognition; rehabilitation; attentional regulation; working memory

Outcome Measures

Primary Outcomes (1)

• Change in Goal Processing Scale Scores

  Functional/Behavioral evaluation

  Baseline, Week 6-8, Week 12-16, and Week 18-24

Secondary Outcomes (1)

• Change in Scores on Neuropsychological Assessment Measures

  Baseline, Week 6-8, Week 12-16, and Week 18-24

Study Arms (2)

Neural Pathfinder Training

EXPERIMENTAL

Neural Pathfinder training (PATH) will involve 6-8 weeks of training sessions with a trainer (1-2 hour sessions, average of 1 session per week), up to 3 hours of telephone contact with the trainer (about 15 minutes per week), and approximately 20 hours of home practice). Some subjects will only receive the PATH intervention.

Behavioral: Neural Pathfinder Training

Brain Health Education

ACTIVE COMPARATOR

Brain Health Education (EDU) will involve 6-8 weeks of training sessions with a trainer (1-2 hour sessions, average of 1 session per week), up to 3 hours of telephone contact with the trainer (about 15 minutes per week), and approximately 20 hours of home practice). Some subjects will only receive the EDU intervention. Some subjects will receive both the PATH and EDU interventions.

Behavioral: Brain Health Education

Interventions

Neural Pathfinder Training BEHAVIORAL

Neural Pathfinder Training consists of game-based computerized training tools that target goal-directed attention regulation. Training will involve 6-8 weeks of 1-2 hour in-person or remote sessions with a trainer involving an average of one session per week; about 15 minutes a week of telephone contacts with the trainer; and approximately 20 hours of homework (35 minutes/5 days a week), consisting of short attentional regulation practice and computer-assisted cognitive training game play.

Neural Pathfinder Training

Brain Health Education BEHAVIORAL

Brain Health Education (EDU) will involve 6-8 weeks of 1-2 hour in-person or remote sessions covering brain anatomy and health with a trainer involving an average of one session per week; about 15 minutes a week of telephone contacts with the trainer; and approximately 20 hours of homework (35 minutes/5 days a week), consisting of computer game play involving decision-making and motor skills.

Brain Health Education

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans with a history of traumatic brain injury
• Age 24-65
• Mild residual dysfunction in executive control
• In the chronic, stable phase of recovery (\>6 months from injury)
• On stable psychoactive medications (\> 30 days)
• Able and willing to participate in training and assessments.

You may not qualify if:

• Unstable medical, neurologic or psychiatric conditions
• Severe cognitive dysfunction
• Ongoing illicit drug or alcohol abuse
• Severe depression, severe anxiety or severe PTSD precluding participation
• Poor English comprehension.

Sponsors & Collaborators

• VA Northern California Health Care System: lead
• United States Department of Defense: collaborator

Study Sites (2)

VA Northern California Health Care System

Martinez, California, 94553, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Anthony J-W Chen, MD

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 20, 2013
• Study Start: June 1, 2013
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: May 29, 2018

Record last verified: 2018-05

Locations

US (2)