Clinical trial NCT03642158: rTMS for Cognitive Rehabilitation After TBI
Official title: Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Traumatic Brain Injury
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Virginia Commonwealth Neurotrauma Initiative
First posted: 2018-08-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Auditory target detection task
timeFrame: 10 minutes
measure: Ruffs 2 and 7 selective attention test
timeFrame: ~5 minutes
measure: DKEFS Verbal Fluency
timeFrame: 10 minutes
measure: California Verbal Learning Test II
timeFrame: 10 minutes
Secondary outcomes:
measure: EEG
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veterans Affairs Medical Center
state: Virginia
Study officials:
References: