Efficacy and Safety of Accelerated Sequential Dual-site Continuous Theta Burst Stimulation in Obsessive Compulsive Disorder and Neurobiological Correlates of Treatment Response: A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
Obsessive-Compulsive Disorder (OCD) is a chronic, relapsing neuropsychiatric disorder characterised by intrusive thoughts (obsessions) and repetitive behaviours (compulsions). It affects 2–3% of the population and significantly impairs personal, occupational, and social functioning. While selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioural therapy (CBT) are first-line treatments, approximately 40% of patients are refractory to these interventions. Despite advancements in pharmacotherapy and psychotherapy, treatment-resistant OCD remains a major clinical challenge. Functional neuroimaging implicates hyperactivity in the cortico-striato thalamo-cortical (CSTC) circuit, particularly the supplementary motor area (SMA), in pathophysiology of OCD. Non-invasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), have demonstrated potential in modulating these circuits through stimulation of neuroanatomical targets implicated in OCD. Deep TMS is FDA-approved for OCD and the most evidence-based TMS approaches target the right dorsolateral prefrontal cortex (DLPFC) and supplementary motor area using inhibitory protocols, with good response in 40–50% of patients.
Theta burst stimulation (TBS), a patterned form of rTMS, can induce neuroplastic changes in a shorter duration and at lower intensities. Continuous TBS (cTBS) offers inhibitory effects and has shown promise when applied to SMA. Recent international studies and systematic review report that accelerated TBS protocols—multiple daily sessions over a short span are safe, well-tolerated, and result in faster clinical improvement. However, there is a critical lack of studies from India evaluating accelerated cTBS in OCD. Additionally, Indian healthcare systems can benefit from shorter-duration interventions to improve accessibility and adherence. Thus, this randomised controlled study will assess the role of sequential accelerated cTBS over Right DLPFC, followed by Bilateral SMA (supplementary motor area), and compare it with sham stimulation, potentially offering a safe and rapid-acting adjunct treatment for OCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age Range between 18 to 60 years.
- •2.Diagnosis of Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria.
- •3.Moderate to severe OCD, indicated by a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of more than
- •4.Inadequate response to at least one adequate trial of a selective serotonin reuptake inhibitor (SSRI) and/or structured Cognitive Behavioral Therapy (CBT) 5.Ability to understand and sign informed consent documents.
排除标准
- •1.Current diagnosis of schizophrenia, bipolar disorder, or primary major depressive disorder.
- •2.Substance use disorder within the past 6 months (excluding caffeine or nicotine).
- •3.Any major neurological disorder (e.g., epilepsy, Parkinson’s disease, or history of significant head trauma).
- •4.Any serious or unstable medical condition that might interfere with participation.
- •5.Currently pregnant or breastfeeding.
研究者
Godi Sangha Mitra
AIIMS Mangalagiri