rTMS: A Treatment to Restore Function After Severe TBI

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT02366754

Run by

Edward Hines Jr. VA Hospital

People needed

58

Starts

2016-02-01

Expected to finish

2021-02-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwestern University — Chicago, Illinois, United States (enrolling)
• Edward Hines, Jr. VA Hospital — Hines, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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