rTMS for Cognitive Rehabilitation After TBI

Not Applicable

Completed

• Conditions: Cognitive Impairment; Traumatic Brain Injury

• Registration Number: NCT03642158
• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Auditory target detection task	10 minutes	subjects listen to a series of sounds, and will monitor for a specific sounds.
California Verbal Learning Test II	10 minutes	subjects are required to learn and recall an unfamiliar word list.
DKEFS Verbal Fluency	10 minutes	a measure of internal search and selection process, requires subject to generate several lists of items.
Ruffs 2 and 7 selective attention test	~5 minutes	subjects must visually search for the numbers 2 and 7 among other distractors.

Secondary Outcome Measures

Name	Time	Method
EEG	10 minutes	resting state power spectra of EEG will be collected to analyze.

Trial Locations

Locations (1)

Hunter Holmes McGuire Veterans Affairs Medical Center; 🇺🇸 Richmond, Virginia, United States