Accelerated deep intermittent theta-burst stimulation of medial prefrontal/anterior cingulate cortex for medication-resistant obsessive-compulsive disorder: A multi-site randomised sham-controlled trial
概览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- Shyam Sundar Arumugham
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) severity score from baseline
概览
简要总结
This multi-site, randomised, double-blind, sham-controlled trial aims to evaluate the clinical efficacy, safety, and neurobiological effects of accelerated deep intermittent theta-burst stimulation (iTBS) targeting the medial prefrontal and anterior cingulate cortices in individuals with medication-resistant OCD. The study will enrol 72 patients with OCD and 36 healthy volunteers across two Indian centres: NIMHANS, Bengaluru and CIP, Ranchi. Patients will be randomised to receive either active or sham iTBS over five consecutive days (six sessions per day; total 30 sessions). The primary outcome is the change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score one week after completion of phase-1 treatment. Secondary outcomes include changes in Clinical Global Impressions Severity (CGI-S), Depression Anxiety Stress Scales (DASS), cognitive task performance, cortical excitability and connectivity (EEG), and resting-state functional connectivity (fMRI). Healthy controls will undergo the same stimulation protocol to characterise normative neurophysiological changes and support identification of biomarkers associated with treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary diagnosis of obsessive-compulsive disorder as per DSM-5 criteria, confirmed using the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND).
- •Inadequate response to at least one adequate trial of serotonin reuptake inhibitor.
- •On stable psychotropic medications for a minimum of 8 weeks.
- •Not undergoing cognitive behavioural therapy at the time of recruitment.
- •Yale-Brown Obsessive Compulsive Scale score of 16 or higher.
- •Clinical Global Impressions Severity score of 4 or higher.
排除标准
- •Presence of comorbid psychotic disorders, bipolar disorder, or active substance use disorder (except nicotine or caffeine dependence).
- •Active suicidality.
- •History suggesting intellectual disability.
- •Contraindications to repetitive transcranial magnetic stimulation or magnetic resonance imaging.
- •Presence of unstable medical conditions or severe neurological disorders requiring immediate medical attention.
结局指标
主要结局
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) severity score from baseline
时间窗: 1 week after intervention
次要结局
- Change in resting-state functional connectivity in anterior cingulate and prefrontal regions,(Change in ACC functional connectivity, MRS glutamate levels and amplitude of ERN)
- HAM-A and HAM-D scores(1 week after end of treatment)
- Change in YBOCS, HAM-A and HAM-D score at the end of phase 2 and Phase 3(6 weeks and 12-18 weeks after the end of treatment)
研究者
Shyam Sundar Arumugham
National Institute of Mental Health and Neuro Sciences