Phase 3
N=34
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
TBI Depression
Bottom Line
View on ClinicalTrials.gov: NCT02367521 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale — 23.154; 23.076; 13.154; 12.706 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS) (Combination_product); Sham Comparator: Sham Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale |
23.154; 23.076; 13.154; 12.706; 12.538; 12.647 | — |
| PRIMARY Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S) |
4.846; 5; 2.308; 2.824; 2.385; 2.471 | — |
| PRIMARY Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI) |
0.462; 1.294; 0.077; 0.706; 0.154; 0.353 | — |
| SECONDARY Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT) |
43.2; 42.4; 45.4; 43.1 | — |
| SECONDARY Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST) |
5.5; 6; 6; 6 | — |
| SECONDARY Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST) |
26; 11; 10.5; 8.667 | — |
| SECONDARY Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST) |
74.5; 68.857; 67; 69.667 | — |
| SECONDARY Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score |
68.411; 71.432; 56.439; 68.015 | — |
| SECONDARY Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT) |
23.077; 25.938; 23.538; 25.5 | — |
| SECONDARY Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT) |
44.364; 43.071; 49.111; 47.692 | — |
| SECONDARY Delayed Recall as Assessed by Brief Visual Memory Test (BVMT) |
9.23; 9.688; 8.308; 8.813 | — |
| SECONDARY Immediate Recall as Assessed by Brief Visual Memory Test (BVMT) |
22.846; 24.313; 23.231; 21.438 | — |
| SECONDARY Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score |
27.725; 31.434; 23.133; 30.027 | — |
| SECONDARY Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire |
12.636; 12.75; 7.5; 7.824; 6.917; 7.588 | — |
| SECONDARY Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS) |
34.154; 41.706; 15; 24.063; 11.462; 17.294 | — |
| SECONDARY Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI) |
13.846; 13.688; 10.23; 10.647; 9.846; 10.176 | — |
| SECONDARY Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS) |
9.769; 9.412; 5.846; 7.563; 5.923; 6.063 | — |
| SECONDARY Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA) |
25.769; 26.5; 26; 26.875 | — |
| SECONDARY Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS) |
51.23; 56.125; 40.545; 40.727; 44.222; 42.786 | — |
| SECONDARY Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ) |
26.769; 23.125; 11.833; 11.765; 14.154; 11 | — |
| SECONDARY Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS) |
28.308; 41.176; 28.385; 23.375; 20.769; 29.938 | — |
| SECONDARY Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS) |
2.308; 3; 1.308; 1.118; 0.692; 0.471 | — |
| SECONDARY Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire |
14.231; 10.625; 21.538; 18.471; 22.231; 17.647 | — |
| SECONDARY Presence of Social Connections as Assessed by the Social Ties Checklist (STC) |
3.154; 4.563; 3.077; 3.765; 2.769; 3.471 | — |
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
- Adults aged 18 and over
- H/o closed head injury
- Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI)
- 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
- Subjects with skull fracture
- Subjects who meet DoD criteria for severe TBI
- Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics.
- Subjects who are medically unstable
- History of active substance abuse x 1 month
- Current psychotic illness
- Evidence of frontal lesions on brain scan.
- 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
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire
- Electroconvulsive therapy (ECT) treatment within 6 months prior to the screening visit
- History of treatment with rTMS therapy for any disorder
- History of treatment with Vagus Nerve Stimulation (VNS)
- History of treatment with Deep Brain Stimulation (DBS)
- Cardiac pacemakers, implanted medication pumps, intracardiac lines,
- 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.
- Implanted neurostimulators
- Known or suspected pregnancy
- Investigators, personnel affiliated with this study, and their immediate families.
Data sourced from ClinicalTrials.gov (NCT02367521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.