rTMS for Cognitive Rehabilitation After TBI

NCT03642158 | Completed FDA Device

• 1 other identifier: 02332
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• Auditory target detection task

  subjects listen to a series of sounds, and will monitor for a specific sounds.

  10 minutes

• Ruffs 2 and 7 selective attention test

  subjects must visually search for the numbers 2 and 7 among other distractors.

  ~5 minutes

• DKEFS Verbal Fluency

  a measure of internal search and selection process, requires subject to generate several lists of items.

  10 minutes

• California Verbal Learning Test II

  subjects are required to learn and recall an unfamiliar word list.

  10 minutes

Secondary Outcomes (1)

• EEG

  10 minutes

Study Arms (2)

Active TMS

ACTIVE COMPARATOR

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

Sham TMS

SHAM COMPARATOR

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

Interventions

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.

Active TMS; Sham TMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Virginia Commonwealth Neurotrauma Initiative: collaborator

Study Sites (1)

Hunter Holmes McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Brain Injuries, Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research, Parksinon's Disease Education, Research and Clinical Center (PADRECC)

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: December 1, 2017
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)