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| Name | Class |
|---|---|
| Virginia Commonwealth Neurotrauma Initiative | UNKNOWN |
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A novel and promising therapy for cognitive dysfunction is non-invasive brain stimulation, of which transcranial magnetic stimulation (TMS) is a form. TMS is currently FDA-approved for use in depression and migraine. It is under investigation for use in a number of other neurologic and psychiatric disorders. In addition to its potential to improve affective symptoms, recent research has suggested that TMS targeted to select cortical regions can also improve cognition. In trials of TMS therapy for psychiatric disorders, several studies have shown benefits for cognitive function alongside symptom amelioration. In healthy persons, a course of stimulation of the parietal area improved objective measures of learning and memory. Among persons with TBI, there have been case reports supporting improvement in cognitive function and postconcussive symptoms; however, there have not yet been any controlled studies of TMS for TBI-related cognitive dysfunction.
Subjects with a history of TBI will be recruited into this double-blind, sham controlled, crossover with washout study design. Study will involve one week (5 consecutive days) of treatment, a 7 day off period, followed by a second week of rTMS treatment. Motor threshold will determine level of stimulation, and active rTMS stimulation will occur of the right DLPFC. Subjects will be paid for their time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TMS | Active Comparator | Subjects receive rTMS over the right DLPFC, in 2 second bursts at 10 Hz, followed by a 19 second break, for a total of 20 minutes. Stimulator intensity is set to 80% of motor threshold on day one, and 100% of motor threshold for the remainder of intervention. This paradigm is continued for 5 consecutive days. |
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| Sham TMS | Sham Comparator | Identical to active arm, but stimulator intensity is reduced to 30% of motor threshold, and the stimulator coil is oriented tangentially to the skull to "stimulate" air space above the head instead of cortical tissue. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation | Device | repetitive Transcranial Magnetic Stimulation (rTMS) utilizes a magnetic coil of wire to non-invasively and painlessly activate small sections of the brain through the skull. |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory target detection task | subjects listen to a series of sounds, and will monitor for a specific sounds. | 10 minutes |
| Ruffs 2 and 7 selective attention test | subjects must visually search for the numbers 2 and 7 among other distractors. | ~5 minutes |
| DKEFS Verbal Fluency | a measure of internal search and selection process, requires subject to generate several lists of items. | 10 minutes |
| California Verbal Learning Test II | subjects are required to learn and recall an unfamiliar word list. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| EEG | resting state power spectra of EEG will be collected to analyze. | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2022 | Apr 7, 2022 | 4 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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double blinded
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |