Accelerated Continuous Theta-burst Stimulation (acTBS) for Suicidal Ideation in the Psychiatric Inpatient Setting: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Suicidal Ideation Attributes Scales (SI-DAS)
研究概览
简要总结
This is a pilot study to analyze the benefit of accelerated continuous Transcranial magnetic stimulation for inpatient subjects suffering with suicidal ideation. This study will enroll 40 inpatient subjects recruited from the Resnick Neuropsychiatric hospital. Subjects will be blinded and randomized to active or sham TMS treatment and will receive up to 5 assigned treatments per day. Subjects will also be asked to complete mood surveys throughout their participation. Participation in this study will last 7-10 days depending on scheduling.
详细描述
1.0 SPECIFIC AIMS
Suicide is a leading cause of death worldwide. In the United States, someone commits suicide every 13 minutes. Few treatments exist apart from in-patient hospitalization, medication, and psychotherapy. Repetitive transcranial magnetic stimulation (rTMS) is an efficacious treatment for major depressive disorder (MDD), and may hold therapeutic potential for suicidality, specifically. Novel treatment methods including accelerated theta-burst stimulation (aTBS) allow compressed treatment times and courses, making aTBS ideally suited to an inpatient environment.
In the accelerated continuous theta-burst stimulation for suicidal inpatients (ACT-SI) pilot study, our objective is to examine the feasibility and therapeutic benefit of adding accelerated cTBS to the right orbitofrontal cortex (R-OFC) to standard inpatient treatment in a proof-of-concept, open-label feasibility study. The hypothesis for this study is that active acTBS will be well-tolerated, and lead to a decrease in suicidal ideation over four treatment days.
2.0 RATIONALE
Suicide is a leading cause of death worldwide. Completed suicide significantly, and negatively, affects the individual's family unit, community, and society. Research examining risk factors suggest access to lethal means, accompanied by a specific intent and plan remain significant indicators of acute risk, while a history of suicidal and parasuicidal behaviors, mental health diagnosis (in particular depression), male gender, and history of abuse are common static risk indicators. Psychiatric and legal interventions, including inpatient admission, typically focuses on limiting access to lethal means, and blunting the effect of life stressors, to the greatest extent possible.
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
- •Inpatients admitted for "suicidality" with a documented diagnosis of MDD
- •Between the ages of 18 and 65
- •No safety concerns endorsed on the Screening 13-item Questionnaire for rTMS Candidates16
- •Have not received single-pulse or repetitive-TMS in the past, i.e. considered "TMS naïve".
排除标准
- •(1) lifetime diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, current psychotic symptoms (2) a history of epilepsy or any other major neurological disorder (3) Any exclusion on the 13-item Questionnaire for rTMS Candidates (4) diagnosis of borderline personality disorder, assessed on a case by case basis (5) concomitant major unstable medical illness (6) current withdrawal from psychoactive substances (7) history of failed brain stimulation (i.e. rTMS, ECT, VNS, DBS, TNS in the past)
研究组 & 干预措施
Sham
All parameters will be programmed in the same way as active treatment, however, the treatment will be delivered on the side of the coil that has an internal (hidden) metal shield that will prevent magnetic energy from reaching the skull and brain. Neither the technician, treating physician, nor the patient, will know whether the treatment was delivered from the sham or active side of the coil. The same auditory and tactile cues will be present during active and sham treatment as electrodes will be placed on the scalps of each participant (whether receiving active or sham treatment) that deliver some electrical sensation.
干预措施: Sham Comparator (Device)
Active acTBS
For the first three treatments, the study psychiatrist will set treatment intensity to 90% MT, and gradually increase intensity to 120% MT over 20 seconds to maximize tolerability. Subsequent treatment sessions (treatment 4 and onward) will begin, and remain, at 120% MT.
Treatment will occur 4-5 times a day, separated by an at least 45-min interval between sessions on consecutive weekdays.
干预措施: accelerated Thetaburst stimulation (Device)
结局指标
主要结局
Change in Suicidal Ideation Attributes Scales (SI-DAS)
时间窗: Baseline to Final visit
This 5-item questionnaire is a self-report measure that asks completers to rate the frequency, controllability, closeness to attempt, distress, and interference of suicidal thinking with daily activities from 0-10, with 10 indicating extreme intensity. The SIDAS takes approximately 30-60 seconds to complete and has excellent internal reliability, sensitivity, and specificity. The score is calculated as the sum of the five items. Scores of 21 or above denote high suicidal ideation. A lower score indicates improvement in suicidality.
Change in Inventory of Depressive Symptom (Self-report)
时间窗: Baseline to final visit
The 30-item questionnaire used to assess the severity of depressive symptoms. The scale covers symptoms such as as mood reactivity, distinct mood quality, diurnal mood variation, irritable mood, anxious mood, capacity for pleasure, sexual interest, bodily aches and pains, panic or phobic symptoms, digestive problems, interpersonal rejection sensitivity, and leaden paralysis. The sum of the 30 items yields the overall score. A higher score indicates worsening in depressive symptoms. Score ranges from 0 to 84.
次要结局
未报告次要终点
研究者
Andrew F. Leuchter
Principal Investigator
University of California, Los Angeles