rTMS for Cognitive Rehabilitation After TBI

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status: Completed

Conditions: Traumatic Brain Injury; Cognitive Impairment

Treatments: Device: repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT03642158

02332

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Active TMS

Active Comparator group

Description:

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.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation

Sham TMS

Sham Comparator group

Description:

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.

Treatment:

Device: repetitive Transcranial Magnetic Stimulation