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Remotely Deployed TBI Study (RD)

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ClinicalTrials.gov Identifier: NCT01882244
Recruitment Status : Active, not recruiting
First Posted : June 20, 2013
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
VA Northern California Health Care System

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.

Condition or disease Intervention/treatment Phase
Brain Injury Behavioral: Neural Pathfinder Training Behavioral: Brain Health Education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Remotely Deployed Training for Cognitive Impairment Associated With TBI
Study Start Date : June 2013
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: Neural Pathfinder Training
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
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.

Active Comparator: Brain Health Education
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
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 Measures :
  1. Change in Goal Processing Scale Scores [ Time Frame: Baseline, Week 6-8, Week 12-16, and Week 18-24 ]
    Functional/Behavioral evaluation


Secondary Outcome Measures :
  1. Change in Scores on Neuropsychological Assessment Measures [ Time Frame: Baseline, Week 6-8, Week 12-16, and Week 18-24 ]
    Battery of Neuropsychological Tests



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882244


Locations
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United States, California
VA Northern California Health Care System
Martinez, California, United States, 94553
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
VA Northern California Health Care System
United States Department of Defense
Investigators
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Principal Investigator: Anthony J-W Chen, MD San Francisco VA Medical Center

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Responsible Party: VA Northern California Health Care System
ClinicalTrials.gov Identifier: NCT01882244     History of Changes
Other Study ID Numbers: RD2013-04-17
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Keywords provided by VA Northern California Health Care System:
traumatic brain injury
cognition
rehabilitation
attentional regulation
working memory
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries