Accelerated Repetitive Transcranial Magnetic Stimulation in Hospitalized Patients With Obsessive-Compulsive Disorder: a Feasibility and Mechanistic RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Self-Reported Severity of Adverse Effects [Safety]
研究概览
简要总结
This study investigates a new treatment approach for Obsessive-Compulsive Disorder (OCD), a condition characterized by unwanted repetitive thoughts and behaviors. The goal is to determine whether combining specialized inpatient care with repetitive Transcranial Magnetic Stimulation (rTMS) is feasible, well-tolerated, and effective. rTMS is a non-invasive procedure that uses magnetic pulses to stimulate specific areas of the brain. In this study, two types of rTMS will be tested: deep TMS (dTMS) and intermittent theta burst stimulation (iTBS). Both treatments will be administered using an accelerated protocol, involving multiple sessions per day over a two-week period.
Patients will be randomly assigned to one of three groups: two groups will receive either dTMS or iTBS combined with Exposure and Response Prevention (ERP), a recognized psychotherapy for OCD; the third group will receive only ERP without rTMS.
Participant Requirements next to treatment:
Questionnaires: Patients will complete surveys before the treatment period, immediately after the treatment period, and four weeks post-treatment.
MRI & EEG: Patients will undergo brain imaging (MRI) and brain wave (EEG) recordings before and after the treatment period.
Adverse Effects Diary: Patients will maintain a daily log of any side effects experienced during the treatment period.
The study aims to assess the feasibility, safety, and effectiveness of this combined treatment approach and to examine its effects on underlying brain processes related to clinical outcomes.
详细描述
This study aims to explore the combination of specialized inpatient care for Obsessive-Compulsive Disorder (OCD) with treatment using repetitive Transcranial Magnetic Stimulation (rTMS) in patients diagnosed with OCD. Specifically, the investigators seek to assess the feasibility, desirability, and tolerability of this combined approach, as well as its clinical and neural effects.
The study protocol consists of three arms. All arms include Exposure and Response Prevention (ERP), an established psychotherapeutic treatment for OCD. Two arms will investigate two different types of rTMS: conventional deep TMS (dTMS) and intermittent theta burst stimulation (iTBS). Both rTMS treatments will be administered using an accelerated protocol, involving four sessions per day. The third arm consists of ERP without any form of neuromodulation (i.e., treatment-as-usual).
Study Design:
This is a randomized clinical trial (RCT) evaluating the feasibility, efficacy, safety, and suitability of the two types of accelerated rTMS protocols, in addition to ERP therapy in patients with OCD. The study also aims to investigate the neural mechanisms underlying these treatment approaches.
Patients will be randomly assigned by a computer program to one of three treatment groups. All groups will receive ERP. Two groups will receive either iTBS or dTMS combined with ERP, and the third group will receive ERP without rTMS.
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)
盲法说明
Family and relatives of the patient also remain unaware of the treatment arm.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65
- •Hospitalization for Obsessive-Compulsive Disorder (OCD)
- •Participation in Exposure and Response Prevention Therapy
- •Significant OCD, as measured by a Y-BOCS score of 20 or higher (moderate to severe OCD symptoms)
排除标准
- •Acute suicidality: Individuals presenting with current suicidal ideation or behavior are excluded to ensure participant safety.
- •Psychotic disorder: patients with active psychotic disorders are excluded due to the complexity of their condition and potential interactions with the study protocol.
- •Current substance use disorder: active substance use disorders are exclusionary to prevent confounding effects on study outcomes.
- •Deep Brain Stimulation (DBS) for OCD: participants with an implanted DBS device for OCD are excluded due to potential interference with the study's interventions and safety concerns.
研究组 & 干预措施
dTMS + ERP
20 hospitalized patients who will receive deep TMS treatment with H7 coil next to psychofarmacological treatment and exposure responseprevention for OCD.
干预措施: dTMS (Procedure)
dTMS + ERP
20 hospitalized patients who will receive deep TMS treatment with H7 coil next to psychofarmacological treatment and exposure responseprevention for OCD.
干预措施: ERP (Behavioral)
iTBS + ERP
20 hospitalized patients who will receive a specific form of repetitive transcranial magnetic stimulation: intermittent thetaburst stimulation (iTBS) with F8 coil; next to psychofarmacological treatment and exposure responseprevention for OCD.
干预措施: iTBS (Procedure)
iTBS + ERP
20 hospitalized patients who will receive a specific form of repetitive transcranial magnetic stimulation: intermittent thetaburst stimulation (iTBS) with F8 coil; next to psychofarmacological treatment and exposure responseprevention for OCD.
干预措施: ERP (Behavioral)
Control (ERP)
20 hospitalized patiënts who will receive psychofarmacological treatment and exposure responseprevention for OCD. No TMS.
干预措施: ERP (Behavioral)
结局指标
主要结局
Self-Reported Severity of Adverse Effects [Safety]
时间窗: From start to end of rTMS treatment period (2 weeks)
Severity of specific adverse effects (e.g., headache, tooth pain, scalp discomfort, fatigue, etc.) will be assessed daily using a visual analogue scale (VAS) ranging from 0 (not at all) to 10 (extremely severe). Scores will be collected daily for the duration of the treatment. Unit of Measure: VAS score (0-10) per adverse effect
Incidence of Any Self-Reported Adverse Effect [Safety]
时间窗: From start to end of rTMS treatment period (2 weeks)
Occurrence of any self-reported adverse effect (i.e., VAS \> 0 for any symptom) during the rTMS treatment period. Unit of Measure: Number of participants reporting ≥1 adverse effect
Participant Retention Rate [Feasibility]
时间窗: From enrollment to end of treatment (approximately 2 weeks of rTMS)
Percentage of participants who complete the full rTMS treatment protocol (32 sessions over 2 weeks) out of those who consented and were randomized. Unit of Measure: Percentage of participants completing protocol
次要结局
- Functional MRI-Based Resting-State Functional Connectivity(Before and after each treatment arm (2 weeks).)
- Structural MRI-Based Grey Matter Volume(Before and after each treatment arm (2 weeks).)
- DTI-Based White Matter Microstructure(Before and after each treatment arm (2 weeks).)
- ASL-Based Resting Cerebral Blood Flow(Before and after each treatment arm (2 weeks).)
- EEG-Based Resting-State Oscillatory Power(Before and after each treatment arm (2 weeks).)
- EEG-Based Resting-State Functional Connectivity(Before and after each treatment arm (2 weeks).)
研究者
Dienstpsychiatrie
Prof. Dr. Chris Baeken
University Hospital, Ghent