Clinical trial NCT02367521: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: TBI Depression
Keywords: TBI Depression
co-morbid psychiatric symptoms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2015-02-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
timeFrame: Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
measure: Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
measure: Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
Secondary outcomes:
measure: Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
timeFrame: Mean at baseline and 16 weeks
measure: Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)
timeFrame: Mean at baseline and 16 weeks
measure: Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)
timeFrame: Mean at baseline and 16 weeks
measure: Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)
timeFrame: Mean at baseline and 16 weeks
measure: Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
timeFrame: Mean at baseline and 16 weeks
measure: Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
timeFrame: Mean at baseline and 16 weeks
measure: Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
timeFrame: Mean at baseline and 16 weeks
measure: Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
timeFrame: Mean at baseline and 16 weeks
measure: Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
timeFrame: Mean at baseline and 16 weeks
measure: Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
timeFrame: Mean at baseline and 16 weeks
measure: Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
timeFrame: Baseline, 4, 8, 12, and 16 weeks
measure: Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
timeFrame: Mean at baseline and 16 weeks
measure: Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
measure: Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
measure: Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
measure: Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
measure: Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
measure: Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
timeFrame: Mean at baseline, 4, 8, 12, and 16 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
References: