A naturalistic, quasi- experimental study comparing the effectiveness of accelerated TBS targeting left SMA and left DLPFC among patients with obsessive compulsive disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of acTBS protocol targeting left supplementary motor area and aiTBS at left dorsolateral prefrontal cortex in reducing the YBOCS score among patients with Obsessive Compulsive Disorder
研究概览
简要总结
| Patients attending Adult Psychiatry OPD, Department of Psychiatry, KGMU, on all OPD days clinically diagnosed with OCD as per DSM 5 and on a stable dose of medication as per selection criteria, the patients will continue to receive SSRI (Equivalent dose of Tab Fluoxetine 40 to 80 mg/day) medication during the treatment. Rescue medication may be used in the case of anxiety and insomnia including Clonazepam (up to 1mg/day) and Zolpidem (up to 10mg/day) respectively. Now, planned to receive either aiTBS protocol targeting DLPFC or acTBS protocol targeting SMA. |
The patient will be assessed for inclusion in the study. A written informed consent will be taken from the patients prior to inclusion in the study. Following enrollment, the socio-demographic and clinical details of the patient will be recorded using Semi-Structured Proforma. Baseline clinical variables will be measured using scales, i.e. TMS screening checklist for screening patients suitable for TMS, Y-BOCS (yale brown obsessive compulsive Scale) to assess the severity of OCD, Patient Health Questionnaire-9(PHQ-9) to assess the severity of comorbid depression, Generalized Anxiety Disorder Screener(GAD-7) to assess the severity of comorbid anxiety, WHO5 well-being index for the psychological wellbeing of the patient. Patients fulfilling the selection criteria will be recruited in the study if required may be hospitalized for rTMS. A total of 20 sessions of TBS, 2 sessions per/day at an interval of 15 minutes will be delivered over a period of two weeks following treatment protocol as described below.
(Protocol 1 at left DLPFC; aiTBS with an amplitude of 100%, frequency, 20 trains, pulses in a train 300, and total pulses 600 will be delivered in a single session.
Protocol 2 at left SMA: acTBS with an amplitude of 100%, a frequency of 5Hz, 2 trains, pulses in a train 300 and a total of pulses 600 will be delivered in a single session.)
Assessment will be done at baseline, week 1, week 2, and week 4 of the study. In case the patient develops any minor adverse effects due to rTMS, it will be managed conservatively. If any serious adverse effect develops, the patient will be dropped from the study and appropriate medical care will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients with a diagnosis of OCD as per DSM 5 criteria 2 Age between 18 and 60 years 3 OCD with severity moderate or higher YBOCS MORE THAN 15 4 Patient on a stable dose of SSRI medication Fluoxetine equivalent dose of 40 to 80 mg per day for at least 1 month and a maximum duration of 3 months 5 Participant agreeing to give written informed consent.
排除标准
- •1 Other comorbid psychiatric illnesses (except tobacco use disorder and mild to moderate depression) 2 Any medical morbidity that significantly interferes with psychiatric assessmenent.
结局指标
主要结局
To compare the effectiveness of acTBS protocol targeting left supplementary motor area and aiTBS at left dorsolateral prefrontal cortex in reducing the YBOCS score among patients with Obsessive Compulsive Disorder
时间窗: Assessment will be done at baseline, week 1, week 2, and week 4 of the study.
次要结局
- Secondary objective To determine the change in resting motor threshold (RMT) among patients with Obsessive Compulsive Disorder with acTBS protocol targeting left supplementary motor area versus aiTBS at left dorsolateral prefrontal cortex(To determine the change in depressive symptoms and subjective well-being among patients with Obsessive Compulsive Disorder with acTBS protocol targeting left supplementary motor area versus aiTBS at left dorsolateral prefrontal cortex)
研究者
Priyanshi chaudhary
King Georges Medical University