A Randomized, Double-Blind, Clinical Trial to Study the Efficacy and Mechanisms of Transcranial Alternating Current Stimulation (tACS) Concurrent With Exposure-based Cognitive-Behavioral Therapy (CBT) for Obsessive-Compulsive Disorder (OCD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To explore the differences in treatment efficacy between active and sham transcranial alternating current stimulation (tACS) concurrent with exposure and response prevention (ERP)(tACS+ERP) in patients with obsessive-compulsive disorder (OCD).
研究概览
简要总结
This study aims to evaluate the feasibility and clinical outcome of the Exposure-based Cognitive-Behavioral Therapy (CBT) concurrent with Transcranial Alternating Current Stimulation (tACS) using individualized stimulation frequency in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).
详细描述
The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT (ERP) combined with tACS over the prefrontal cortex (mPFC) in treatment of OCD patients. 62 OCD patients will be randomized into two groups (ERP+active tACS, ERP+sham tACS stimulation). All patients will be received 10 sessions of individual ERP in a two-month period, including 8 sessions of concurrent tACS with ERP (tACS+ERP). Based on the EEG parameters, individualized modeling was conducted to determine specific stimulation parameter schemes (stimulation frequency).
The treatment program consists of a total of 10 sessions, with the first and last sessions being psychological therapy only. The middle eight sessions will involve concurrent transcranial alternating current stimulation (tACS) and exposure and response prevention (ERP). The timing of assessments is designed to capture changes in symptom severity during the intervals between consecutive combined treatment sessions.
Three independent evaluators will assess the severity of patients' obsessive-compulsive symptoms using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at four time points:
Baseline assessment (prior to the start of treatment); After the first combined session (Session 2) and before the second combined session (Session 3); After the fourth combined session (Session 5) and before the fifth combined session(Session 6); After the eighth combined session (Session 9) and before the final treatment session (Session 10).
Patients will also undergo electroencephalography (EEG) assessments at each evaluation time point. The current study aims to explore whether the administration of individualized stimulation frequency tACS in conjunction with ERP can enhance the efficacy of ERP, providing early evidence for revealing the potential neural mechanisms underlying this treatment. Additionally, participants will undergo magnetic resonance imaging (MRI) scans at treatment baseline and after the completion of the full course of treatment.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigators recruited outpatient adults with OCD confirmed by the Mini-International Neuropsychiatric Interview (MINI). The following inclusion and
排除标准
- •were also applied:
- •Inclusion Criteria:
- •18-60 years old
- •With at least 9 years of education
- •Y-BOCS score ≥16
- •No history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary)
- •Medication-free or had received stable medication for at least 8 weeks before entering the study and continued the same medication throughout the study
- •Exclusion Criteria:
- •History of serious medical, neurological illness or other psychotic disorders other than OCD
- •OCD symptoms are severe, preventing the patient from completing the required assessment and examination
- •Serious suicide risk
- •Women who are pregnant or planning to become pregnant
- •Currently taking antiepileptic medication
- •Clinically significant physical illnesses or laboratory test abnormalities that have clinical significance
- •Previous completion of a full course of CBT/ERP treatment
研究组 & 干预措施
active tACS+exposure based CBT
The exposure and response prevention (ERP) treatment concurrently with an anode transcranial alternating current stimulation over the mPFC will be applied 8 times (tACS+ERP, 8 sessions) in the whole treatment.
干预措施: ERP combined with high-definition active tACS (Combination Product)
sham tACS +exposure based CBT
the exposure and response prevention (ERP) treatment concurrently with an sham transcranial alternating current stimulation over the mPFC will be applied 8 times (sham tACS+ERP, 8 sessions) in the whole treatment.
干预措施: ERP combined with sham tACS (Combination Product)
结局指标
主要结局
To explore the differences in treatment efficacy between active and sham transcranial alternating current stimulation (tACS) concurrent with exposure and response prevention (ERP)(tACS+ERP) in patients with obsessive-compulsive disorder (OCD).
时间窗: baseline, 2weeks, 4weeks,8 weeks (baseline, after Session 2, 5, 10)
The primary outcome measure of this study is the change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores from baseline at the completion of the 8th tACS + ERP treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS)：The total score of the scale ranges from 0 to 40, with higher scores indicating more severe symptoms.
次要结局
未报告次要终点
研究者
Zhen Wang
vice-president
Shanghai Mental Health Center