Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
NCT ID: NCT01908647
Last Updated: 2014-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Exp RT fMRI/Exp Cognitive Training
Both experimental conditions.
RT fMRI
Real-time fMRI with neurofeedback.
Cognitive Training
Computer based attention training.
Exp RT fMRI/Ctrl Cognitive training
Experimental real-time fMRI and control cognitive training.
RT fMRI
Real-time fMRI with neurofeedback.
Control Cognitive Training
Computer-based games used as a control for the computer based cognitive training intervention.
Ctrl RT fMRI/Exp Cognitive Training
Control RT fMRI (real-time functional MRI) and experimental cognitive training.
Cognitive Training
Computer based attention training.
Control RT fMRI
Control condition for real-time fMRI.
Ctr RT fMRI/Ctr Cognitive Training
Control real-time fMRI and control cognitive training.
Control RT fMRI
Control condition for real-time fMRI.
Control Cognitive Training
Computer-based games used as a control for the computer based cognitive training intervention.
Interventions
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RT fMRI
Real-time fMRI with neurofeedback.
Cognitive Training
Computer based attention training.
Control RT fMRI
Control condition for real-time fMRI.
Control Cognitive Training
Computer-based games used as a control for the computer based cognitive training intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
No
Sponsors
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The Geneva Foundation
OTHER
Massachusetts Institute of Technology
OTHER
Van Boven, Robert W., M.D.
OTHER
Responsible Party
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Principal Investigators
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Robert Van Boven, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Geneva Foundation
Locations
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Carl R Darnall Army Medical Center (CRDAMC)
Fort Hood, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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W81XWH-11-2-0180
Identifier Type: -
Identifier Source: org_study_id
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