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Remotely Deployed TBI Study (RD)

Primary Purpose

Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neural Pathfinder Training
Brain Health Education
Sponsored by
VA Northern California Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring traumatic brain injury, cognition, rehabilitation, attentional regulation, working memory

Eligibility Criteria

24 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • VA Northern California Health Care System
  • San Francisco VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neural Pathfinder Training

Brain Health Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Goal Processing Scale Scores
Functional/Behavioral evaluation

Secondary Outcome Measures

Change in Scores on Neuropsychological Assessment Measures
Battery of Neuropsychological Tests

Full Information

First Posted
June 11, 2013
Last Updated
May 24, 2018
Sponsor
VA Northern California Health Care System
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01882244
Brief Title
Remotely Deployed TBI Study
Acronym
RD
Official Title
Remotely Deployed Training for Cognitive Impairment Associated With TBI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Northern California Health Care System
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The objective of this research is to develop remotely deployed computer-assisted training interventions, including software tools and training protocols, to address cognitive neurologic impairment associated with TBI, improving cognitive functioning and thus increasing quality of life. These tools will be built on a strong foundation of cognitive neuroscience, empiric evidence and advanced clinical care, while addressing practical issues such as distance and therapist/patient time limitations. This research involves two phases: User testing and Assessment/Training. Assessment and Training Assessments: The potential effects of remotely administered training will be assessed using neuropsychological tests of complex attention, executive function and memory, a test of functioning in challenging real world situations involving multitasking and goal management, and questionnaires assessing cognitive and emotional functioning in personal life. Neurocognitive testing and functional evaluation sessions take 2- 3 hours each, or about 5 hours combined. The subject is free to take breaks throughout testing sessions, which will take place over one or two days. Subjects participate in assessments up to four times (Baseline, after 6-8 weeks; 12-16 weeks; and at 18-24 weeks), or up to 20 hours (5 hours x 4 time points). The investigators anticipate about 30 subjects will participate in assessments and training. Experimental Intervention I: The Pathfinder training protocol will include supervised attentional regulation training sessions, either in-person or via the VA's video tele-health (VTEL) system, and home play of a computer game. Trainers will also call subjects between each supervised session to (i) check that patients are initiating home play (and help problem-solve or provide motivation, if necessary), and (ii) encourage transfer and generalization of learning, as per protocol. Home play will be configured to allow for about 35 minutes of play each day between supervised sessions. After the end of home game play, some additional time will be allowed for continued practice and application of trained skills in personal life. Experimental Intervention II: Brain Health Education will consist of training sessions, either in-person or via the VA's video tele-health (VTEL) system, and home play of a computer game. The Brain Health Education protocol will be based on a curriculum already developed, designed to facilitate learning of TBI-relevant information. Trainers will also call subjects between each supervised session to (i) check that patients are initiating home play (and help problem-solve or provide motivation, if necessary). Home play will be configured to allow for about 35 minutes of play each day between supervised sessions. After the end of home game play, some additional time will be allowed for continued practice and review of TBI-relevant information. Subjects will participate in either one or both experimental interventions, which are matched for time commitment. Participation in interventions will include weekly in-person or remote 1-2 hour sessions with a trainer over a period of 6-16 weeks. In addition to weekly training sessions, study activities will include about 15 minutes of weekly telephone contact with the trainer and about 35 minutes a day of playing a computerized game at home during the same period. Therefore, total training time range is approximately 43-93 hours, depending on whether participation includes one or both interventions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
traumatic brain injury, cognition, rehabilitation, attentional regulation, working memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neural Pathfinder Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Brain Health Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neural Pathfinder Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Goal Processing Scale Scores
Description
Functional/Behavioral evaluation
Time Frame
Baseline, Week 6-8, Week 12-16, and Week 18-24
Secondary Outcome Measure Information:
Title
Change in Scores on Neuropsychological Assessment Measures
Description
Battery of Neuropsychological Tests
Time Frame
Baseline, Week 6-8, Week 12-16, and Week 18-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J-W Chen, MD
Organizational Affiliation
San Francisco VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Northern California Health Care System
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

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Remotely Deployed TBI Study

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