rTMS for Cognitive Rehabilitation After TBI

NCT ID: NCT03642158

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-11-30

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.

Conditions

Cognitive Impairment; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Active TMS

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.

Group Type: ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Sham TMS

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.

Group Type: SHAM_COMPARATOR

repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth Neurotrauma Initiative

UNKNOWN

Sponsor Role: collaborator

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

George Gitchel

Director of Clinical Research, Parksinon's Disease Education, Research and Clinical Center (PADRECC)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hunter Holmes McGuire Veterans Affairs Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

02332

Identifier Type: -

Identifier Source: org_study_id