rTMS for Cognitive Rehabilitation After TBI

Traumatic Brain Injury Clinical Trial

Official title:

Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642158
• Other study ID #: 02332
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2021
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Impairment
• Traumatic Brain Injury

Intervention

Device:
• repetitive 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.

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire Veterans Affairs Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	Virginia Commonwealth Neurotrauma Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory target detection task	subjects listen to a series of sounds, and will monitor for a specific sounds.	10 minutes
Primary	Ruffs 2 and 7 selective attention test	subjects must visually search for the numbers 2 and 7 among other distractors.	~5 minutes
Primary	DKEFS Verbal Fluency	a measure of internal search and selection process, requires subject to generate several lists of items.	10 minutes
Primary	California Verbal Learning Test II	subjects are required to learn and recall an unfamiliar word list.	10 minutes
Secondary	EEG	resting state power spectra of EEG will be collected to analyze.	10 minutes