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Completed

NCT Number: NCT03642158

rTMS for Cognitive Rehabilitation After TBI

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.

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Key information

Conditions

Cognitive Impairment Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurocognitive Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • one or more mild to moderate TBIs*;
  • at least one year but no more than 20 years from worst injury;
  • ability to complete cognitive and neurophysiological testing;
  • available for duration of study;
  • between 18 and 65 years of age;
  • mild or greater cognitive symptoms on the TBI-QOL Cognition General Concerns scale

Exclusion criteria

  • severe or penetrating TBI;
  • history of psychotic or manic illness;
  • history of intracranial surgery;
  • history of skull fracture;
  • history of seizures in candidate or candidate's family
  • ferrous metallic implants or implantable medical device;
  • medications that are known to reduce seizure threshold;
  • pregnancy.
  • history of multiple sclerosis, stroke, brain tumor, epilepsy

Treatment and study plan

repetitive transcranial magnetic stimulation

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.

Primary outcomes

  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 outcomes

  1. EEG

    Time frame: 10 minutes

    resting state power spectra of EEG will be collected to analyze.

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Collaborators

  • Virginia Commonwealth Neurotrauma Initiative

Registry information

Official study title

Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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