A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of Accelerated BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) Protocol in Obsessive-Compulsive Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Yale Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
详细描述
This study is a randomized, double-blind clinical trial designed to compare the efficacy of active rfTMS coil targeting the mPFC and ACC with an inactive sham treatment. Conducted over a 13-week period, the trial includes 39 treatment sessions following an accelerated protocol. Eligible participants are randomly assigned in a 1:1 ratio to either the active treatment or sham group. Each daily treatment comprises three sessions separated by 1-hour intervals, resulting in a total treatment duration of 2.5 hours per day. The treatment regimen is structured into three distinct phases (Figure 1): (1) an acute phase (week 1), in which participants are treated for five consecutive days (totaling 15 sessions); (2) a maintenance phase (weeks 2-6), during which participants are treated once per week for five weeks (totaling 15 sessions); and (3) a follow-up phase during which participants are treated every visit at weeks 8, 10, and 13 (totaling 9 sessions). Imaging sessions are conducted at baseline and at the end of the maintenance session.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Diagnosed as suffering from OCD according to the DSM-V.
- •Subjects with a YBOCS score of >
- •If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial.
- •If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of this treatment). CBT can be with teletherapy but must be for a minimum of ten sessions with a symptom checklist, hierarchy, with exposure and response prevention therapy.
- •Have negative or justified responses by the investigator to all questions listed on the Transcranial Magnetic Stimulation Safety Screening questionnaire (TASS).
- •According to the treating physician the subject is compliant with taking medication, if applicable.
- •Subject is capable and willing to provide informed consent and assent.
- •Willing and able to adhere to the treatment schedule.
- •All comorbid diagnoses have been stable for 3 months and anticipated to be stable for the 3 months treatment duration.
排除标准
- •Subjects diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
- •Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
- •Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.
- •History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
- •Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
- •History of head injury necessitating cranial surgery or prolonged coma.
- •History of any ferromagnetic of conductive material in the head including the eyes and ears (outside the mouth).
- •Known history of any metallic particles in the eye, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes).
- •History of significant hearing loss.
- •Subjects with significant neurological disorder or insult
- •Substance use disorder within the past 6 months (except nicotine and caffeine and based on the doctor's judgment).
- •Currently participating in another therapeutic clinical study.
- •Suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure, unstable blood sugar, or acute, unstable cardiac disease.
- •Subject on high doses of antidepressant or psychotropic medications, which are known to lower the seizure threshold. Subject is currently on Clomipramine.
- •Significant possibility of death within eighteen months of baseline.
- •Planned surgeries that will interrupt the study schedule within four months of baseline.
- •Women who are breast-feeding.
- •Women who are pregnant or with suspected pregnancy.
- •Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale (YBOCS)
时间窗: 6 weeks
Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups. Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
次要结局
- Yale Brown Obsessive Compulsive Scale (YBOCS)(13 weeks)
研究者
Dor Shukrun
PhD Student
Ben-Gurion University of the Negev