Traumatic Brain InjuryNCT01908647
Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
A study testing RT fMRI and Cognitive Training in people with Traumatic Brain Injury and Post Traumatic Stress Disorder, run by Van Boven, Robert W., M.D. at 1 site in United States.
Trial summary
In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Traumatic Brain Injury, Post Traumatic Stress Disorder
- What is being tested?
- RT fMRI and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2015
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild TBI: PTA/confusion≤1 hour immediately after injury; or LOC <30 min [69] confirmed by the Ohio confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
- Age 18-45 years
- Right handed [70].
- Minimum of 4 months and within 36 months post-injury
- Can participate in fMRI and outcome assessment
- Adequate visual, auditory, sensory-motor function for training program.
- Fluent in English
- Persistent cognitive dysfunction confirmed by an objective measure
Who cannot join
- History of hypoxic event
- Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
- Current illicit drug use or ETOH abuse
- Contraindications to MRI (metal, pregnant, pacemaker, claustrophobia, etc.).
- Unwilling or unable (e.g. language barrier) to participate
- Hospitalization during study
Show all 11Show fewer
- Current Med Board for discharge, Litigation/ + malingering test [71]
- Use of medications to enhance cognitive function (e.g. Ritalin)
- Initial Glascow Coma Score <13 or penetrating head injury
- Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS; 111). Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment.
- Subjects should not be enrolled in a concurrent TBI clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carl R Darnall Army Medical Center (CRDAMC)
Fort Hood, Texas, 76544
Robert Van Boven, M.D., 847-477-9317, robert.vanboven@gmail.com
Michel-Alexis Courines, M.D., 254-288-8309, michel.a.courtines.mil@mail.mil
About this study
In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training tasks on cognitive learning and symptoms. In addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.
- Being tested
- RT fMRI, Cognitive Training, Control RT fMRI, Control Cognitive Training
- Keywords
- mTBI, PTSD
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT fMRIBehavioural
Also called Real-time fMRI
Real-time fMRI with neurofeedback.
Cognitive TrainingBehavioural
Computer based attention training.
Control RT fMRIBehavioural
Control condition for real-time fMRI.
Control Cognitive TrainingBehavioural
Computer-based games used as a control for the computer based cognitive training intervention.
| Study group | Role | What they receive |
|---|---|---|
| Exp RT fMRI/Exp Cognitive Training | Experimental | Both experimental conditions. Receives: Behavioral: RT fMRI; Behavioral: Cognitive Training |
| Exp RT fMRI/Ctrl Cognitive training | Experimental | Experimental real-time fMRI and control cognitive training. Receives: Behavioral: RT fMRI; Behavioral: Control Cognitive Training |
| Ctrl RT fMRI/Exp Cognitive Training | Experimental | Control RT fMRI (real-time functional MRI) and experimental cognitive training. Receives: Behavioral: Cognitive Training; Behavioral: Control RT fMRI |
| Ctr RT fMRI/Ctr Cognitive Training | Sham comparator | Control real-time fMRI and control cognitive training. Receives: Behavioral: Control RT fMRI; Behavioral: Control Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological assessments
A composite score based on four primary domains (learning, memory, working memory and executive function).
Measured: 8 weeks
Secondary outcomes (4)
Participant-reported outcomes
A measure of the impact of program use on the participants' own view of their impairment and function
Measured: 8 weeks
Working/School Status
A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week
Measured: 8 weeks
Exercise Based Assessments
Three sets of assessments that are closely modeled on study-related exercises in the auditory, visual, and cognitive control modules, and include auditory speed of processing, visual speed of processing, and cognitive control speed of processing.
Measured: 4 and 8 weeks
Functional Assessments
Two types of functional measures: a sensitive directly observed performance measure designed originally for normal cognitive aging (timed instrumental activities of daily living, TIADL), and a well-accepted clinical impression measure (the Mayo-Portland Adaptability Inventory, MPAI-4).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startApr 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Boven, Robert W., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- The Geneva Foundation, Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Robert Van Boven, M.D., Principal investigator, The Geneva Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908647
- Sponsor's protocol ID
- W81XWH-11-2-0180
- Status last verified
- Apr 2014
- First submitted
- 22 Jul 2013
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
- ClinicalTrials.gov ID
- NCT01908647
- Acronym / sponsor ID
- W81XWH-11-2-0180
- Keywords
- mTBI, PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Van Boven, Robert W., M.D.University, hospital or other
- Collaborators
- The Geneva Foundation, Massachusetts Institute of Technology
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 26 Jul 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.
In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training tasks on cognitive learning and symptoms. In addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exp RT fMRI/Exp Cognitive Training | Experimental | Behavioral: RT fMRI, Behavioral: Cognitive TrainingBoth experimental conditions. |
| Exp RT fMRI/Ctrl Cognitive training | Experimental | Behavioral: RT fMRI, Behavioral: Control Cognitive TrainingExperimental real-time fMRI and control cognitive training. |
| Ctrl RT fMRI/Exp Cognitive Training | Experimental | Behavioral: Cognitive Training, Behavioral: Control RT fMRIControl RT fMRI (real-time functional MRI) and experimental cognitive training. |
| Ctr RT fMRI/Ctr Cognitive Training | Sham comparator | Behavioral: Control RT fMRI, Behavioral: Control Cognitive TrainingControl real-time fMRI and control cognitive training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Mild TBI: PTA/confusion≤1 hour immediately after injury; or LOC <30 min [69] confirmed by the Ohio confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
- Age 18-45 years
- Right handed [70].
- Minimum of 4 months and within 36 months post-injury
- Can participate in fMRI and outcome assessment
Key exclusion criteria (11 listed)
- History of hypoxic event
- Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
- Current illicit drug use or ETOH abuse
- Contraindications to MRI (metal, pregnant, pacemaker, claustrophobia, etc.).
- Unwilling or unable (e.g. language barrier) to participate
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 |
|---|---|---|
| RT fMRIAlso: Real-time fMRIReal-time fMRI with neurofeedback. | Behavioural | Exp RT fMRI/Ctrl Cognitive training, Exp RT fMRI/Exp Cognitive Training |
| Cognitive TrainingComputer based attention training. | Behavioural | Ctrl RT fMRI/Exp Cognitive Training, Exp RT fMRI/Exp Cognitive Training |
| Control RT fMRIControl condition for real-time fMRI. | Behavioural | Ctr RT fMRI/Ctr Cognitive Training, Ctrl RT fMRI/Exp Cognitive Training |
| Control Cognitive TrainingComputer-based games used as a control for the computer based cognitive training intervention. | Behavioural | Ctr RT fMRI/Ctr Cognitive Training, Exp RT fMRI/Ctrl Cognitive training |
Primary outcome
Neuropsychological assessments
Time frame: 8 weeks
A composite score based on four primary domains (learning, memory, working memory and executive function).
4 secondary outcomes
Participant-reported outcomes
Time frame: 8 weeks
Working/School Status
Time frame: 8 weeks
Exercise Based Assessments
Time frame: 4 and 8 weeks
Functional Assessments
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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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.
Robert Van Boven, M.D. principal investigator
The Geneva Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT fMRI and Cognitive Training in people with Traumatic Brain Injury and Post Traumatic Stress Disorder, run by Van Boven, Robert W., M.D. at 1 site 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 8 inclusion and 11 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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Contact Kaela Miller (737-346-7017, kmiller@genevausa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological assessments (time frame: 8 weeks). 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 28 Apr 2014.