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rTMS for Cognitive Rehabilitation After TBI

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ClinicalTrials.gov Identifier: NCT03642158
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Virginia Commonwealth Neurotrauma Initiative
Information provided by (Responsible Party):
George Gitchel, 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Traumatic Brain Injury Device: repetitive Transcranial Magnetic Stimulation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double blinded
Primary Purpose: Health Services Research
Official Title: Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: 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.
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.

Sham Comparator: 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.
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.




Primary Outcome Measures :
  1. Auditory target detection task [ Time Frame: 10 minutes ]
    subjects listen to a series of sounds, and will monitor for a specific sounds.

  2. Ruffs 2 and 7 selective attention test [ Time Frame: ~5 minutes ]
    subjects must visually search for the numbers 2 and 7 among other distractors.

  3. DKEFS Verbal Fluency [ Time Frame: 10 minutes ]
    a measure of internal search and selection process, requires subject to generate several lists of items.

  4. California Verbal Learning Test II [ Time Frame: 10 minutes ]
    subjects are required to learn and recall an unfamiliar word list.


Secondary Outcome Measures :
  1. EEG [ Time Frame: 10 minutes ]
    resting state power spectra of EEG will be collected to analyze.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642158


Locations
United States, Virginia
Hunter Holmes McGuire Veterans Affairs Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: George T Gitchel, PhD    804-675-6300    george.gitchel@va.gov   
Contact: Sheryl Underwood    804-675-5000 ext 5391    sheryl.underwood@va.gov   
Principal Investigator: George T Gitchel, PhD         
Sub-Investigator: Laura Franke, PhD         
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Virginia Commonwealth Neurotrauma Initiative

Responsible Party: George Gitchel, Director of Clinical Research, Parksinon's Disease Education, Research and Clinical Center (PADRECC), Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03642158     History of Changes
Other Study ID Numbers: 02332
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Brain Injuries
Cognitive Dysfunction
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cognition Disorders
Neurocognitive Disorders
Mental Disorders