Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/2/2018 |
| Start Date: | March 2015 |
| End Date: | October 1, 2017 |
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.
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.
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.
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: Vani Rao, MD
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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