Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS) (Combination Product)
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
干预措施: Sham Comparator: Sham Treatment (Device)
结局指标
主要结局
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
时间窗: Mean at baseline, 4, 8, 12, and 16 weeks
The BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
时间窗: Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, \>/= 23 = Very Severe Depression.
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
时间窗: Mean at baseline, 4, 8, 12, and 16 weeks
The CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S is only performed at baseline. The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
次要结局
- Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)(Mean at baseline and 16 weeks)
- Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)(Mean at baseline and 16 weeks)
- Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score(Mean at baseline and 16 weeks)
- Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)(Mean at baseline and 16 weeks)
- Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)(Mean at baseline and 16 weeks)
- Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire(Baseline, 4, 8, 12, and 16 weeks)
- Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)(Mean at baseline, 4, 8, 12, and 16 weeks)
- Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)(Mean at baseline and 16 weeks)
- Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score(Mean at baseline and 16 weeks)
- Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)(Mean at baseline, 4, 8, 12, and 16 weeks)
- Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)(Mean at baseline and 16 weeks)
- Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)(Mean at baseline and 16 weeks)
- Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)(Mean at baseline and 16 weeks)
- Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)(Baseline, 4, 8, 12, and 16 weeks)
- Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)(Baseline, 4, 8, 12, and 16 weeks)
- Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)(Mean at baseline and 16 weeks)
- Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)(Mean at baseline, 4, 8, 12, and 16 weeks)
- Presence of Social Connections as Assessed by the Social Ties Checklist (STC)(Mean at baseline, 4, 8, 12, and 16 weeks)
- Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)(Baseline, 4, 8, 12, and 16 weeks)
- Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)(Mean at baseline, 4, 8, 12, and 16 weeks)
- Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire(Mean at baseline, 4, 8, 12, and 16 weeks)