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| Name | Class |
|---|---|
| The Geneva Foundation | OTHER |
| Massachusetts Institute of Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exp RT fMRI/Exp Cognitive Training | Experimental | Both experimental conditions. |
|
| Exp RT fMRI/Ctrl Cognitive training | Experimental | Experimental real-time fMRI and control cognitive training. |
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| Ctrl RT fMRI/Exp Cognitive Training | Experimental | Control RT fMRI (real-time functional MRI) and experimental cognitive training. |
|
| Ctr RT fMRI/Ctr Cognitive Training | Sham Comparator | Control real-time fMRI and control cognitive training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT fMRI | Behavioral | Real-time fMRI with neurofeedback. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological assessments | A composite score based on four primary domains (learning, memory, working memory and executive function). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant-reported outcomes | A measure of the impact of program use on the participants' own view of their impairment and function | 8 weeks |
| Working/School Status | A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaela Miller | Contact | 737-346-7017 | kmiller@genevausa.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Van Boven, M.D. | The Geneva Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R Darnall Army Medical Center (CRDAMC) | Recruiting | Fort Hood | Texas | 76544 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Cognitive Training | Behavioral | Computer based attention training. |
|
| Control RT fMRI | Behavioral | Control condition for real-time fMRI. |
|
| Control Cognitive Training | Behavioral | Computer-based games used as a control for the computer based cognitive training intervention. |
|
| 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. | 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). | 8 weeks |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |