Study of the Effectiveness of Transcranial Direct Current Stimulation on Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Yale-Brown's obsession-compulsion scale (Y-BOCS)
研究概览
简要总结
The usual management of Obsessive Compulsive Disorders is based on cognitive-behavioural psychotherapy, as well as the use of serotonergic antidepressants. Nevertheless, a significant proportion of patients (40% to 60%) are non-responders to these conventional therapies, and remain severely handicapped.
transcranial Direct current stimulation (tDCS) has already proven its effectiveness, in addition to drug approaches, in various clinical settings, such as depression or acoustic-verbal hallucinations. This technic appears to be an extremely interesting alternative This is a non-invasive neuromodulation technique (application of a low intensity direct current (1 to 2 mA) between two electrodes positioned on the scalp) that allows the neural activity of different brain areas to be modulated simultaneously. It is a simple and inexpensive technique with excellent tolerance.
详细描述
Obsessive-compulsive disorder (OCD) is a common psychiatric condition (prevalence 2-3%), with a chronic course, and significantly impairs the quality of life and functioning of sufferers quality of life and functioning. Cognitive-behavioral psychotherapies are the standard treatment, and the use of serotonergic antidepressants. Nevertheless, a significant proportion of patients (40% to 60%) are non-responders to these conventional therapies, and remain severely handicapped (Pallanti & Quercioli, 2006).
Recent advances in neuroimaging techniques have enabled us to pinpoint the neuroanatomical basis of OCD. of OCD, notably involving dysfunctions affecting cortico-striato-pallido-thalamocortical circuits.
This knowledge of the pathophysiology of the disease has led to the development of focal intervention strategies, aimed at modulating the activity of these cortico-subcortical loops in order to reduce obsessive-compulsive symptomatology, using invasive (deep brain stimulation via stereotactic electrode implantation) or non-invasive (repeated trancranial magnetic stimulation or rTMS) procedures or rTMS). In the case of rTMS, recent studies have demonstrated the efficacy of a single treatment in patients with resistant OCD. the efficacy of low-frequency stimulation of the pre-supplementary motor area (pre-SMA), a brain area involved in cognitive inhibition processes. However, these methods have limitations invasive nature in the case of deep brain stimulation, and the need for an expensive technical for rTMS.
There is therefore a clear need to develop new therapeutic approaches for OCD, combining efficacy efficacy, safety and patient acceptance.
In this context, transcranial direct current stimulation (tDCS) is an extremely interesting alternative. This non-invasive neuromodulation technique involves applying a low-intensity direct current current (1 to 2 mA) between two electrodes positioned on the scalp. It enables modulate neuronal activity in different brain areas simultaneously. It also has the advantage of being the advantage of simple, low-cost use, as well as excellent tolerance.
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
- Triple (Participant, 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
- •Presenting an obsessive-compulsive disorder according to the criteria of Diagnostic and Statistical Manual of Mental Disorders 5, evolving for at least two years
- •Of significant clinical intensity: Yale-Brown's obsession-compulsion scale ≥ 16/40 continuously over the last 6 months. This criteria of persistent severity over the last 6 months will be explored by an in-depth clinical interview at the inclusion visit (Baseline BL)
- •Resistant despite treatment with: 2 serotonergic antidepressants, each received for at least 8 weeks, at the maximum recommended or tolerated dosage AND behavioural and cognitive therapy for at least 6 months
- •Drug treatment unchanged for at least 12 weeks
排除标准
- •Patient with psychotic disorder, bipolar mood disorder, substance abuse or dependence (excluding tobacco)
- •Patient at risk of suicide (score ≥ 2 on item 10 of the Montgomery-Åsberg depression rating scale)
- •Contraindications to the practice of transcranial direct stimulation : history of cerebral pathology, intracranial hypertension, neurosurgery, cephalic metal implant, pacemaker
- •Unbalanced epilepsy
- •Previous use of transcranial direct stimulation (problem of maintaining the integrity of the blind procedure)
- •Pregnancy or breastfeeding in progress, woman in a state of procreation without effective contraception (a urine pregnancy test will be performed)
- •Scalp skin pathology
研究组 & 干预措施
Transcramial Direct current stimulation
Implement of Transcramial Direct current stimulation
干预措施: Transcramial Direct current stimulation (Device)
Placebo
干预措施: Placebo (Device)
结局指标
主要结局
Yale-Brown's obsession-compulsion scale (Y-BOCS)
时间窗: 3 month
The evolution (continuous parameter) of this score between the beginning of treatment (Baseline BL) and the visit at 3 month will be calculated. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is a scale for assessing obsessive symptomatology scale for assessing obsessional symptomatology. It is reliable, accurate and sensitive to therapeutic changes. The French version is well validated. It allows comprehensive assessment and repeated measurement of two types of target symptoms target symptoms: obsessions (score from 0 to 20) and compulsions (score from 0 to 20), leading to an overall severity score of 0 to 40. Developed since 1989, it is the reference measure of OCD in therapeutic studies. A score of 16 or more is frequently used to select obsessive-compulsive subjects for controlled controlled studies. This is a hetero-questionnaire administered in the form of a structured interview.
次要结局
未报告次要终点