Remotely Deployed TBI Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 24 - 65 |
| Updated: | 5/30/2018 |
| Start Date: | June 2013 |
| End Date: | September 30, 2019 |
Remotely Deployed Training for Cognitive Impairment Associated With TBI
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.
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.
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.
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.
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.
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