rTMS: An Experimental Treatment to Restore Function after Severe TBI
Is your loved one in a coma following a traumatic brain injury?
You may be able to enroll them in a research study for an experimental treatment option.
Is your loved one in a coma following a traumatic brain injury? You may be able to enroll them in a research study for an experimental treatment option.
Details for the study
Treatments and/or Procedures
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