Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: TBI Depression
In brief
Traumatic brain injury (TBI) is frequently complicated by depression and other problems such as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and behavioral problems. Untreated depression can lead to reduced productivity and poor global outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of TBI-related depression. The overarching goal of this small study is to determine the effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique. It involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. Adults aged 18 and older, with a history of head injury of mild or moderate severity , who are currently experiencing symptoms of clinical depression may join the study.
Key facts
- Study ID
- NCT02367521
- Run by
- Johns Hopkins University
- People needed
- 70
- Starts
- 2015-03-01
- Expected to finish
- 2017-10-01
- Last updated by the study team
- 2018-08-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 and over
- H/o closed head injury
- Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI)
- Must meet criteria for major depression as assessed by the Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual IV (DSM-IV) and a score greater than 10 on the Hamilton Depression 17 (HAM-D17) Scale
You may not qualify if…
- Subjects with skull fracture
- Subjects who meet DoD criteria for severe TBI
- Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics.
- Subjects who are medically unstable
- History of active substance abuse x 1 month
- Current psychotic illness
- Evidence of frontal lesions on brain scan.
- Individuals with a significant neurological disorders that could increase risk of seizures such as brain tumor, cerebral aneurysm, any h/o seizures and/or family h/o seizures
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire
- Electroconvulsive therapy (ECT) treatment within 6 months prior to the screening visit
- History of treatment with rTMS therapy for any disorder
- History of treatment with Vagus Nerve Stimulation (VNS)
- History of treatment with Deep Brain Stimulation (DBS)
- Cardiac pacemakers, implanted medication pumps, intracardiac lines,
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- Implanted neurostimulators
- Known or suspected pregnancy
- Investigators, personnel affiliated with this study, and their immediate families.
Where it is running
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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