Brain InjuryRDNCT01882244
Remotely Deployed TBI Study
A study testing Neural Pathfinder Training and Brain Health Education in people with Brain Injury, run by VA Northern California Health Care System at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 65 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- Neural Pathfinder Training and Brain Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2013to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Northern California Health Care System
Martinez, California, 94553
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Injury
- Being tested
- Neural Pathfinder Training, Brain Health Education
- Keywords
- traumatic brain injury, cognition, rehabilitation, attentional regulation, working memory
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural Pathfinder TrainingBehavioural
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.
Brain Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Brain Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Goal Processing Scale Scores
Functional/Behavioral evaluation
Measured: Baseline, Week 6-8, Week 12-16, and Week 18-24
Secondary outcomes (1)
Change in Scores on Neuropsychological Assessment Measures
Battery of Neuropsychological Tests
Measured: Baseline, Week 6-8, Week 12-16, and Week 18-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Northern California Health Care System
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Anthony J-W Chen, MD, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882244
- Sponsor's protocol ID
- RD2013-04-17
- Acronym
- RD
- Status last verified
- May 2018
- First submitted
- 11 Jun 2013
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Deployed Training for Cognitive Impairment Associated With TBI
- ClinicalTrials.gov ID
- NCT01882244
- Acronym / sponsor ID
- RD / RD2013-04-17
- Conditions
- Brain Injury
- Keywords
- traumatic brain injury, cognition, rehabilitation, attentional regulation, working memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- VA Northern California Health Care SystemUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Jun 2013
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural Pathfinder Training | Experimental | Behavioral: Neural Pathfinder TrainingNeural 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 | Active comparator | Behavioral: Brain Health EducationBrain 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. |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural Pathfinder TrainingNeural 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. | Behavioural | Neural Pathfinder Training |
| Brain Health EducationBrain 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. | Behavioural | Brain Health Education |
Primary outcome
Change in Goal Processing Scale Scores
Time frame: Baseline, Week 6-8, Week 12-16, and Week 18-24
Functional/Behavioral evaluation
1 secondary outcome
Change in Scores on Neuropsychological Assessment Measures
Time frame: Baseline, Week 6-8, Week 12-16, and Week 18-24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
Related trials for Brain Injury
RecruitingPhase 3
Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study
Traumatic Brain Injury (TBI) Patients
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony J-W Chen, MD principal investigator
San Francisco VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Pathfinder Training and Brain Health Education in people with Brain Injury, run by VA Northern California Health Care System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Goal Processing Scale Scores (time frame: Baseline, Week 6-8, Week 12-16, and Week 18-24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.