Priming in Repetitive Transcranial Magnetic Stimulation (TMSr) in the Adjuvant Treatment of Obsessive Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Yale-Brown Obsessive Compulsive Scale
研究概览
简要总结
Obsessive Compulsive Disorder results in high social impact, affecting quality of life and tending to a chronic course. A considerable proportion of patients, up tp 60%, remain with symptoms even thought treatment is administrated. Therefore, new therapeutic interventions are highly necessary. In this context, repetitive transcranial magnetic stimulation has been used for several psychiatric conditions, including OCD treatment. Moreover, many approaches of neuromodulation seem to reach a better result when used a priming stimulation. In an attemp to optimize particularities of the thecnique applied, this study aims to assess if a priming stimulation with rTMS might impact in a better outcome when compared with rTMS without previous stimulation.
详细描述
This is a randomized, double-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 16 patients, totaling 50 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
In the active priming, the parameters are: frequency of 6 Hz for 10 minutos, 80% do Motor Threshold (MT), 20 trains of 5 seconds, with intertrain interval of 25 seconds, a total f 600 stimulations. The group of innactive priming will have the same parameters, but without active atimulation. After this previous stimulation, all participants will receive the main stimulation: 10 sessions of rTMS, each lasting around 20 minutes, for 5 days a week, during two consecutive weeks.
The target area will be the supplementary motor area. Primary outcome will be assessed by change in Yale-Brown Obsessive Compulsive Scale scores. As secondary outcomes, it will be used HAM-A for anxiety, HAM-D for depression, CGI-S for global clinical impression and SF-36 for quality of life.
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)
盲法说明
Duble (Participant, Investigator) All examiners will be blinded to the type of treatment the patient received (active stimulation or sham) and other assessments. Thus, all guidelines established by CONSORT 2010 (Consolidated Standards of Reporting Trials) will be complied with variable control following systematized and countersigned procedures: random sequence generation, allocation concealment, blinding of participants and professionals, blinding of outcome evaluators and attrition bias (loss analysis using the last observation carried forward method)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being right-handed;
- •Age between 18 and 60;
- •Diagnose of OCD according to DSM-5;
- •Score in YBOCS between 16 and 23;
- •No change in dose prescription in the previous 3 months;
- •Signature of informed consent term.
排除标准
- •Being pregnant;
- •Having cognitive deficit;
- •Diagnose of drug use disorder;
- •In current psychotherapy (or interrupted in less than 3 months);
- •Diagnose of severe Major Depression;
- •Risk of suicide;
- •Patients with metallic implants in the brain;
- •Epileptics.
结局指标
主要结局
Change in Yale-Brown Obsessive Compulsive Scale
时间窗: From date of randomization (1 week before intervention beginning) and up to 8 weeks
It's a 10-item-scale that evaluates the symptoms' severity of Obsessive Compulsive Disorder. Includes five dimensions that evaluate obsessions and compulsions. The ten itens score from 0 (no symptom) to 4 (extreme symptoms), possibly scoring from 0-20 in obsessions' severity, 0-20 in compulsions' severity, with a total 0-40. YBOCS is considered gold standard in evaluating the severity of OCD symptoms.
次要结局
- Change in Clinical Global Impression - Scale(From date of randomization (1 week before intervention beginning) and up to 8 weeks)
- Change in Hamilton Scale for Depression(From date of randomization (1 week before intervention beginning) and up to 8 weeks)
- Change in Medical Outcomes Study 36 - Item Short Form Health Survey(From date of randomization (1 week before intervention beginning) and up to 8 weeks)
- Change in Hamilton Scale for Anxiety(From date of randomization (1 week before intervention beginning) and up to 8 weeks)
研究者
Suellen Andrade
Principal Investigator
Federal University of Paraíba