Expired Study
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Baltimore, Maryland 21224


Purpose:

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.


Criteria:

Inclusion Criteria: 1. Adults aged 18 and over 2. H/o closed head injury 3. Must meet DoD criteria for mild or moderate TBI 4. Must meet criteria for major depression as assessed by the Structured Clinical Interview for DSM- IV (SCID) and a score greater than 10 on the HAM-D17 Exclusion Criteria: 1. Subjects with skull fracture 2. Subjects who meet DoD criteria for severe TBI 3. Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics. 4. Subjects who are medically unstable 5. History of active substance abuse x 1 month 6. Current psychotic illness 7. Evidence of frontal lesions on brain scan. 8. 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 9. Dementia 10. Mini Mental State Exam score of less than or equal to 24 11. A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire 12. ECT treatment within 6 months prior to the screening visit 13. History of treatment with rTMS therapy for any disorder 14. History of treatment with Vagus Nerve Stimulation (VNS) 15. History of treatment with Deep Brain Stimulation (DBS) 16. Cardiac pacemakers, implanted medication pumps, intracardiac lines, 17. 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. 18. Implanted neurostimulators 19. Known or suspected pregnancy 20. Investigators, personnel affiliated with this study, and their immediate families.


NCT ID:

NCT02367521


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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