Transcranial Direct Current Stimulation Associated With Symptom Provocation in the Management of Patients With Treatment-Resistant Obsessive-Compulsive Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 178
- 试验地点
- 6
- 主要终点
- Variation of Yale-Brown Obsessive-Compulsive Scale score
研究概览
简要总结
The goal of this clinical trial is to learn if symptom provocation before transcranial Direct Current Stimulation (tDCS) in Obsessive-Compulsive Disorder (OCD) patients. The main question it aims to answer is:
Can symptom-provocation before tDCS improve therapeutic response in OCD patients ?
Researchers will compare the clinical outcomes of OCD patients having received, in one arm, tDCS and, in the other arm, patients having received tDCS preceded by symptom provocation to see if therapeutic response and various other clinical variables differ.
详细描述
Obsessive-compulsive disorder (OCD) is a chronic and disabling condition affecting 2-3% of the population. Despite evidence-based interventions-cognitive behavioural therapy with exposure and response prevention (ERP) and serotonergic antidepressants, 40-60% of patients exhibit insufficient improvement, highlighting a substantial need for more effective therapeutic strategies.
Neuroimaging and neurophysiological studies consistently implicate dysfunction within cortico-striato-thalamo-cortical circuits, particularly the supplementary motor area (SMA) and orbitofrontal cortex (OFC). These findings have guided the development of neuromodulation interventions targeting these regions. Among them, transcranial direct current stimulation (tDCS) has emerged as a safe, accessible, and potentially effective approach for modulating aberrant neural activity in OCD.
Our research group has previously investigated a bifocal tDCS montage combining cathodal SMA stimulation with anodal right OFC stimulation. In an open-label study of 21 patients, this protocol produced clinically meaningful improvement in 15% of participants and was well tolerated. A subsequent multicentre randomised controlled trial confirmed the feasibility, safety, and potential therapeutic value of this montage, although overall effects remained modest. These findings underscore the need to optimise neuromodulatory strategies in OCD.
One promising direction is to enhance neuromodulation by manipulating the pre-stimulation neural state. Evidence suggests that the impact of tDCS depends on ongoing cortical activity, raising the possibility that activating symptom-relevant circuits immediately before stimulation could potentiate its effects. Pre-stimulation symptom provocation-also referred to as paired associative cognitive stimulation-has shown encouraging results when combined with rTMS in depression, addiction, and post-traumatic stress disorder (PTSD). In PTSD, for example, brief reactivation of traumatic memories prior to stimulation enhanced symptom reduction compared with stimulation alone.
This approach is grounded in the theory of memory, which posits that reactivated memories enter a transiently labile state during which their emotional intensity can be modified. Experimental and clinical studies have demonstrated that targeted interventions delivered during this window can weaken maladaptive emotional memories. In OCD, intrusive thoughts typically accompanied by fear, disgust, or distress may therefore constitute ideal targets for reconsolidation-based modulation.
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 (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
- •Diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5, with a duration ≥ 2 years.
- •Good insight, defined as a BABS score ≤
- •Chronic OCD, with either a Y-BOCS total score > 20 or a subscale score >
- •Treatment-resistant OCD, defined as:
- •failure of ≥ two adequate trials of SSRIs, or
- •failure of one SSRI plus augmentation with an atypical antipsychotic,
- •and/or insufficient response after ≥ one year of cognitive-behavioural therapy.
- •Stable pharmacological treatment (fixed antidepressant dose) for at least 12 weeks prior to inclusion, with no significant improvement during this period.
- •Age 18 to 70 years.
- •Ability to provide informed written consent.
- •Affiliation with the French social security system.
排除标准
- •Women of childbearing potential without effective contraception, or those unwilling to maintain abstinence or contraception.
- •Pregnancy or breastfeeding.
- •Compulsory psychiatric hospitalisation.
- •Legal guardianship or curatorship.
- •Current DSM-5 Axis I disorder other than OCD (schizophrenia spectrum, bipolar disorder, substance use).
- •Current major depressive episode (MADRS > 21).
- •Suicide risk (MADRS item 10 > 3).
- •Dermatological lesions at electrode placement sites.
- •History of traumatic brain injury.
- •Presence of intracranial metal, pacemaker, or epilepsy.
- •Emergency situations or inability to provide informed consent.
研究组 & 干预措施
tDCS
These patients will only receive tDCS
干预措施: tDCS session (Procedure)
tDCS + symptom provocation
These patients will experience symptom provocation followed with tDCS
干预措施: tDCS session (Procedure)
tDCS + symptom provocation
These patients will experience symptom provocation followed with tDCS
干预措施: symptom provocation (Behavioral)
结局指标
主要结局
Variation of Yale-Brown Obsessive-Compulsive Scale score
时间窗: measured at baseline and 42 days after the start of the therapy
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) is a clinician-administered assessment used to measure the severity of obsessive-compulsive disorder (OCD). Scores range from 0 to 40, with higher scores indicating more severe symptoms.
次要结局
- Persistence of variation of Yale-Brown Obsessive-Compulsive Scale score and Obsessive-Compulsive Inventory-Revised(measured between baseline, day 102 / day 162)
- Comparison of Clinical Global Impression Improvement between both groups(Scales assessed at baseline, day 42, 102 and 162)
- Assessment of the Montgomery and Asberg Depression Rating Scale(Scales assessed at baseline, day 42, day 102, day 162)
- Assessment of 36-Item Short Form Health Survey(baseline, day 102, and day 162)
- Analysis of side effects and tolerance of tDCS(Assessed during treatment)
- Analysis of complete response rate(between baseline and days 42 / day 102 / day 162)
- Assessment of the Hospital Anxiety and Depression scale(baseline, day 42, day 102, day 162)
- Assessment of insight with the Brown Assessment of Beliefs Scale(baseline, day 42, day 102, day 162)
- "Echelle d'évaluation Globale du Fonctionnement": Assessment of psychological and socio-professional functioning(baseline, day 102, day 162)
