Recruiting

rTMS

Sponsor:

Edward Hines Jr. VA Hospital

Code:

NCT02366754

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

rTMS

Placebo rTMS

Study Details

Brief summary:

The purpose of this study is to address the need for targeted treatments that induce functional and structural changes in the brain, ultimately improving neurobehavioral functioning, the investigators propose examining the therapeutic effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS). The objective is to improve functional recovery for persons remaining in vegetative (VS) and minimally conscious (MCS) states 3 to 24 months after severe TBI. The approach is to determine the neurobehavioral effect of rTMS, the relationship between neurobehavioral changes and net neural effects, and to identify and define the neural mechanisms related to neurobehavioral improvements by providing 30 active or placebo rTMS sessions.

Conditions

Traumatic Brain Injury

Study ID

NCT02366754

Start date

Feb, 2016

Status verified date

Sep, 2019

Completion date

Feb, 2021

Anticipated

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At study screening, persons have remained in states of Seriously Impaired Consciousness (SIC) for at least 3 and up to 24 months after TBI
  • 18 years of age or older
  • Traumatic Brain Injury etiology
  • Able to participate in all phases of study including follow-up re-admission
  • Able to identify legally authorized representative/surrogate who is able to read and understand informed consent document and provide written consent

Exclusion Criteria:

  • Primary injury is a non-traumatic brain injury (and is not secondary to TBI) (e.g., inflammatory, infectious, toxic and metabolic encephalopathies, anoxia, cancer, ischemic and hemorrhagic stroke)
  • History of TBI, psychiatric illness (DSM criteria) and or organic brain syndrome (e.g. Alzheimer's)
  • Left dorsal lateral pre-frontal cortex (DLPFC) is not accessible (e.g., left frontal lobectomy)
  • Incurred large cortically based ischemic infarction subsequent to TBI (size is determined collectively by neurosurgeon, neurologist, neuroradiologist and principal investigator)
  • At study screening, patient is receiving anti-epileptic medications to control active seizures
  • Have had a documented seizure within 3 months of study screening
  • Are ventilator dependent at time of study screening
  • Have recovered full consciousness at time of study screening as indicated by a Motor Function scale score of 6 and/or a Communication scale score of 2 on the CRS-R
  • Receiving central nervous system (CNS) stimulants that cannot be safely discontinued via titration
  • Patient did not speak English prior to injury (bedside testing is conducted in English)
  • Pregnant
  • Have implanted cardiac pacemaker or defibrillator, cochlear implant or nerve stimulator
  • Have MRI or TMS contraindications such as pre-injury claustrophobia, metal in eyes/face or brain
  • Other medical conditions, that in investigator's opinion, would preclude subject from completing study

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active rTMS

The intervention consists of 30 active rTMS sessions. Each session is comprised of 300 trains of paired pulses with the following parameters: 100µs paired pulses separated by 100ms inter-pulse-intervals and a five second inter-train-interval. Pulse intensity will be set at 110% of each participant's motor threshold. Active rTMS sessions will be provided two times per day with a 70mm figure-of-eight coil over the left dorsolateral prefrontal cortex. Two Magstim-2002 units and a Bistim2 module will be used to administer active rTMS. Participants assigned to the active rTMS group will receive a total of 1.8 seconds of stimulation. Active rTMS will be administered 2 times daily with the following weekly schedule: 2 days of rTMS, 1 day of rest, 2 days of rTMS, 2 days of rest.

sham comparator: Placebo rTMS

The intervention consists of 30 placebo rTMS sessions. Each session is comprised of 300 paired-pulse trains with the following parameters: 100µs paired pulses separated by 100ms inter-pulse-intervals and a five second inter-train-interval. Placebo rTMS sessions will be provided two times per day with a 70mm figure-of-eight coil over the left DLPFC. Two Magstim-2002 units and a Bistim2 module will be used to administer placebo rTMS. The placebo coil simulates magnetic stimulation, but does not actually emit a pulse. Participants assigned to the placebo rTMS group will receive 0 seconds of stimulation. Placebo rTMS will be administered with the following weekly schedule: 2 days of rTMS, 1 day of rest, 2 days of rTMS, 2 days of rest.

Interventions

rTMS

Repetitive TMS is a non-invasive neural stimulation technique achieved via electromagnetic induction. An insulated metal coil is placed on the scalp and short discharges of electric current are directed through the coil producing a magnetic field. This magnetic field is accompanied by an electric field that passes through the skull inducing currents in the tissue beneath the coil. If a cell beneath the coil is viable, then rTMS initiates or inhibits an action potential affecting ongoing neural activity. 30 sessions of active rTMS are provided.

Placebo rTMS

The placebo coil simulates magnetic stimulation, but does not actually emit a pulse. The placebo coil looks, sounds and feels like an active rTMS coil. The placebo coil, visually identical to the active coil, provides a slight sensory sensation and discharge noise (i.e., clicking) nearly identical to that of the active coil.

Primary outcome measure

  • Disability Rating Scale [ Time Frame: Change from Baseline in DRS total score at an average 22 days ]

Central Contacts and Locations

Central contacts

Ann Guernon, MS

708-202-8387ann.guernon@va.gov

Sandra Kletzel, PhD

708-202-5735sandra.kletzel@va.gov

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60141

Contacts

Elyse Walsh, PT, DPT, NCS

708-968-0427Elyse.Walsh@va.gov

Ann Guernon, MS, CCC-SLP/L, CCRC

708-202-8387Ann.Guernon@va.gov

Edward Hines, Jr. VA Hospital

Recruiting

Hines, Illinois, United States, 60141

Contacts

Theresa Pape, DrPH

708-202-4953Theresa.BenderPape@va.gov

Elyse Walsh, PT, DPT, NCS

708-968-0427Elyse.Walsh@va.gov

More Information

Sponsor

Edward Hines Jr. VA Hospital

Last update posted

Sep 6, 2019

Last verified

Sep, 2019

Keywords

  • Transcranial Magnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Edward Hines Jr. VA Hospital on 2019-09-06.