rTMS for Cognitive Rehabilitation After TBI
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/24/2018 |
| Start Date: | December 1, 2017 |
| End Date: | June 30, 2020 |
Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury
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.
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.
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.
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
We found this trial at
1
site
Richmond, Virginia
Principal Investigator: George T Gitchel, PhD
Phone: 804-675-6300
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