Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI) (rTMS TBI)

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: TBI Depression

Treatments: Device: Sham Comparator: Sham Treatment; Combination Product: Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02367521

NA_00090926

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 and over
2. H/o closed head injury
3. Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI)
4. 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

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. Electroconvulsive therapy (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

LFR rTMS

Experimental group

Description:

Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.

Treatment:

Combination Product: Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)

Sham Treatment

Placebo Comparator group

Description:

Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength

Treatment:

Device: Sham Comparator: Sham Treatment