Cognitive Impairment, Traumatic Brain Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICErepetitive Transcranial Magnetic Stimulation
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.
Sponsors
Virginia Commonwealth Neurotrauma Initiative
Hunter Holmes Mcguire Veteran Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. one or more mild to moderate TBIs\*; 2. at least one year but no more than 20 years from worst injury; 3. ability to complete cognitive and neurophysiological testing; 4. available for duration of study; 5. between 18 and 65 years of age; 6. mild or greater cognitive symptoms on the TBI-QOL Cognition General Concerns scale
Exclusion criteria
1. severe or penetrating TBI; 2. history of psychotic or manic illness; 3. history of intracranial surgery; 4. history of skull fracture; 5. history of seizures in candidate or candidate's family 6. ferrous metallic implants or implantable medical device; 7. medications that are known to reduce seizure threshold; 8. pregnancy. 9. history of multiple sclerosis, stroke, brain tumor, epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Auditory target detection task | 10 minutes | subjects listen to a series of sounds, and will monitor for a specific sounds. |
| Ruffs 2 and 7 selective attention test | ~5 minutes | subjects must visually search for the numbers 2 and 7 among other distractors. |
| DKEFS Verbal Fluency | 10 minutes | a measure of internal search and selection process, requires subject to generate several lists of items. |
| California Verbal Learning Test II | 10 minutes | subjects are required to learn and recall an unfamiliar word list. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG | 10 minutes | resting state power spectra of EEG will be collected to analyze. |
Countries
United States
Outcome results
None listed