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

NCT ID: NCT02367521

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-10-01

Brief Summary

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.

Conditions

TBI Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LFR rTMS

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.

Group Type: EXPERIMENTAL

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

Intervention Type: COMBINATION_PRODUCT

LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.

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.

Sham Treatment

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

Group Type: PLACEBO_COMPARATOR

Sham Comparator: Sham Treatment

Intervention Type: DEVICE

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

Interventions

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

LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.

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.

Intervention Type: COMBINATION_PRODUCT

Sham Comparator: Sham Treatment

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

Intervention Type: DEVICE

Other Intervention Names

low frequency right rTMS; Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00090926

Identifier Type: -

Identifier Source: org_study_id