Clinical trial NCT01882244: Remotely Deployed TBI Study
Official title: Remotely Deployed Training for Cognitive Impairment Associated With TBI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injury
Keywords: traumatic brain injury
cognition
rehabilitation
attentional regulation
working memory
Lead sponsor: VA Northern California Health Care System
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2013-06-20
Enrollment: 85
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Goal Processing Scale Scores
timeFrame: Baseline, Week 6-8, Week 12-16, and Week 18-24
Secondary outcomes:
measure: Change in Scores on Neuropsychological Assessment Measures
timeFrame: Baseline, Week 6-8, Week 12-16, and Week 18-24
Other outcomes:
Locations:
city: Martinez
country: United States
facility: VA Northern California Health Care System
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
Study officials:
affiliation: San Francisco VA Medical Center
name: Anthony J-W Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: