An Open Label Study to Compare and Evaluate the Efficacy of the Deep Transcranial Magnetic Stimulation With and Without Exposure and Response Prevention (ERP) to Repetitive Transcranial Magnetic Stimulation With and Without ERP to ERP.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Reduction in the severity of OCD symptoms
研究概览
简要总结
Obsessive Compulsive Disorder is a highly debilitating condition with a lifetime prevalence of 2%-3%, and a notable percentage of patients (40-60%) have a partial or no response to medications. The present gold standard for the treatment of OCD is medications (Selective serotonin reuptake inhibitors (SSRIs) / Clomipramine) + Exposure and Response Prevention (ERP). There is a significant need for alternative novel methods of treatment. One of the novel methods of treating OCD is using magnetic stimulation which has already been successfully used in the treatment of depression. Treating OCD is difficult with regular superficial repetitive Transcranial Magnetic Stimulation (rTMS) hence the need for coils that targets deeper structures. Thus, we are comparing the efficacy of the two different coils from two different manufacturers plus using ERP in combination with the different coils.
- Deep Transcranial Magnetic Stimulation (DTMS) using BrainsWay H7 coil targets deeper structures such as medial prefrontal cortex. The H7 coil has already shown clear evidence in treating patients with OCD and has been approved by the FDA for clinical use.
- Repetitive Transcranial Magnetic Stimulation (rTMS) using MagVenture Cool D-B coil could also target the medial prefrontal cortex. Hence it might also be equally effective as the BrainsWay H7 coil in treating patients with OCD.
详细描述
i. Purpose
a) The purpose of this study is to compare and evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) by MagVenture and Deep Transcranial Magnetic Stimulation (DTMS) by BrainsWay with and without the combination of active Exposure and Response Prevention (ERP) for the treatment of patients with OCD.
ii. Hypothesis a) We hypothesize that the combination of TMS + active ERP will have a superior efficacy in the treatment of OCD. We also hypothesize that MagVenture cool D-B80 coil will be as effective as BrainsWay H7 coil in treating patients with OCD.
iii. Justification
- The Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial by Carmi et al. (2019) had shown significant improvement in OCD symptoms by using the H7 coil and provocation of OCD symptoms before and during treatment.
- The study by Dunlop et al. (2016) has shown reduction in OCD symptom severity by using the Cool D-B80 Coil without provocation.
- There have been no head to head studies comparing the BrainsWay H7 coil and MagVenture Cool D-B80 coil using provocation methods for both coils.
- Also there have been no head to head studies comparing the gold standard treatment of medications + active ERP with medications + active ERP + TMS and medications + TMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Outpatients ii. Men and women 18-70 years of age. iii. Patients diagnosed as suffering from OCD according to the BOCS and YBOCs. iv. Patients had an inadequate/intolerable response to SSRI, CBT (Exposure and Response Prevention) or both.
- •v. Patient is capable and willing to provide informed consent, and their guardians is capable of providing informed consent.
- •vi. Patient is able to adhere to the treatment schedule.
排除标准
- •i. Present suicidal risk is significant as assessed during the investigator's mental status exam and psychiatric interview.
- •ii. Patient has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first-degree relatives.
- •iii. Patient has an 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.
- •iv. Patient has a history of head injury necessitating cranial surgery or prolonged coma.
- •v. Patient has ferromagnetic material in the head including the eyes and ears (outside the mouth) and body.
- •vi. Patient has a history of significant hearing loss. vii. Patients with significant neurological disorder or insult including, but not limited to:
- •Any condition likely to be associated with increased intracranial pressure
- •Space occupying brain lesion
- •History of cerebrovascular accident
- •Transient ischemic attack within two years
- •Cerebral aneurysm
- •Parkinson's disease
- •Huntington's chorea
- •Multiple sclerosis
- •Mini Mental State Exam score of less than or equal to 24 (for adult participants) viii. Patient has a history of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine).
- •ix. Inadequate communication with the patient. x. Patient is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
- •xi. Patients who suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure or acute, unstable cardiac disease.
- •xii. Women who are pregnant or with suspected pregnancy
结局指标
主要结局
Reduction in the severity of OCD symptoms
时间窗: 8 weeks
- The primary outcome measure is the BOCS and YBOCS severity rating scale. The primary efficacy endpoint is the change in BOCS and YBOCS severity score from baseline to the 8-week visit.
次要结局
- Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.(8-12 weeks)