Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- score improvement on the Yale Brown Obsessive and Compulsive Scale after one month
研究概览
简要总结
The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder
详细描述
Total number of scheduled patients to be recruited: 46 We used the effect size of the study of Ruffini and colleagues (2009) in which rTMS was used to target the left orbito frontal cortex to calculate the number of patients to be recruited. With a risk alpha of 5%, a power of 80%, the number of patients to be included was 46 with an anticipated rate of 10% of lost to follow-up patients. (calculation was made on the http://www.spc.univ-lyon1.fr/mfcalc/NSN/assistant.htm)
Statistical analysis to address the primary and secondary objectives:
Chi squared test will be applied for quantitative data.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with OCD according to DSM V criteria
- •YBOCS score of 16 and above, stable (<20% of variation) during at least one month.
- •have received for at least 12 weeks of which 6 weeks was either at the maximum tolerated dose or alternatively the manufacturer's recommended maxi- mum daily dose.
- •age between 18 and 70
- •voluntary and competent to consent
排除标准
- •Major depressive disorder diagnosed with the DSM V criteria with a MADRS score >30 (actual)
- •schizophrenia and other psychotic disorder
- •drugs or alcohol abuse
- •acutely suicidal
- •significant head injury, or of any neurosurgical procedure with implanted material
- •pregnant women
研究组 & 干预措施
active tDCS
patients will received 2 sessions per day for 5 consecutive days. Each session will last 20 minutes. The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline
干预措施: transcranial dirrect current stimulation (Device)
SHAM tDCS
The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the 10 first seconds.
干预措施: Sham tDCS (Device)
结局指标
主要结局
score improvement on the Yale Brown Obsessive and Compulsive Scale after one month
时间窗: 1 month after treatment
% of improvement compare to baseline
次要结局
- score improvement on the Yale Brown Obsessive and Compulsive Scale after 3 months(3 months after treatment)
- Number of responders on the YBOCS(1 month after treatment)
研究者
BATION Rémy
Dr Rémy Bation
Hôpital le Vinatier