Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder (TMS-OCD-EEG)
Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy
Purpose:
This study aims to evaluate the effectiveness of an accelerated intermittent Theta Burst Stimulation (iTBS) protocol-a non-invasive brain stimulation technique-targeted at the dorsomedial prefrontal cortex (dmPFC) and anterior cingulate cortex (ACC) in patients with treatment-resistant Obsessive-Compulsive Disorder (OCD). Additionally, the study seeks to identify electrophysiological biomarkers (such as EEG microstates and heart rate variability) that may predict which patients are most likely to benefit from the treatment.
Methodology:
The study will include 30 patients aged 18-65 diagnosed with OCD according to DSM-5 criteria who have not responded sufficiently to standard treatments. Participants will undergo an intensive 7-day treatment program consisting of 4 iTBS sessions per day (totaling 28 sessions). Clinical symptoms will be assessed before and after the treatment using standardized scales, including the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A). Resting-state EEG measurements and heart rate data will be recorded during and after the sessions to analyze physiological changes.
Goal:
The findings are expected to contribute to the development of personalized neuromodulation protocols and help identify predictors of treatment response for OCD patients.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Sarp Yoldas, MD
- 电话号码：+905069898506
- 邮箱：sarpyoldas@gmail.com
学习地点
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Bakirkoy
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Istanbul、Bakirkoy、土耳其（türkiye）、34153
- 招聘中
- Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi
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接触：
- Sarp Yoldas, MD
- 电话号码：+905069898506
- 邮箱：sarpyoldas@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Being between 18 and 65 years of age.
- Being diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria.
- Non-responsiveness to at least one Selective Serotonin Reuptake Inhibitor (SSRI) treatment at an adequate dose and duration.
- Having a Y-BOCS score of ≥20 following the initial evaluation.
- No change in the current medications within the last 2 months and a commitment to maintaining stable doses throughout the study.
- Providing informed consent and having no contraindications for TMS.
Exclusion Criteria:
- Severe neurological disorders or neurodegenerative diseases.
- Any condition associated with increased seizure risk
- History of cochlear implants, metal implants in the head and neck area, cardiac pacemakers, deep brain stimulation, or vagus nerve stimulation.
- History of neurosurgical intervention.
- General contraindications for Transcranial Magnetic Stimulation therapy.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：TMS Treatment Arm
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Accelerated intermittent Theta Burst Stimulation (iTBS) will be delivered using a MagVenture MagPro R30 stimulator with a Cool D-B80 double cone coil. The stimulation is targeted at the dorsomedial prefrontal cortex (dmPFC) and anterior cingulate cortex (ACC), specifically 25.8% anterior of the nasion-inion distance. The treatment will be applied at 100% of the motor threshold, which is determined via the Extensor Hallucis Longus muscle. The protocol consists of an intensive 7-day program with 4 sessions per day, totaling 28 sessions. Each session delivers 1,800 pulses and lasts approximately 9 minutes. Patients will continue their stable dose of Selective Serotonin Reuptake Inhibitors (SSRIs) throughout the study. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
大体时间：Change from baseline in clinical scales at the end of the 7-day treatment and at follow-up points (1, 3, and 6 months post-treatment)"
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The Y-BOCS is a 10-item clinician-administered scale used to assess the severity of obsessive-compulsive symptoms.
Each item is rated from 0 to 4. The total score ranges from 0 to 40, where higher scores indicate greater symptom severity (32-40: extreme, 24-31: severe, 16-23: moderate, 8-15: mild, 0-7: subclinical).
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Change from baseline in clinical scales at the end of the 7-day treatment and at follow-up points (1, 3, and 6 months post-treatment)"
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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EEG Microstate Analysis Parameters
大体时间：Baseline, Day 7 (after treatment)
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Resting-state EEG data will be analyzed using the MICROSTATELAB v2.1 extension for EEGLAB focusing on the four canonical microstate classes labeled A, B, C, and D. For each participant, four specific spatio-temporal parameters will be calculated to evaluate neural dynamics.
These include Mean Duration which measures the average lifespan of a specific microstate in milliseconds to represent the stability of neural generators, and Occurrence which measures the average frequency of each microstate per second in Hz to reflect activation tendencies.
Additionally, Time Coverage will be calculated as the percentage of total analysis time during which a specific class is dominant, and Transition Probability will be determined to show the likelihood of one microstate class transitioning into another, providing insight into the sequential activation dynamics of the underlying neural networks.
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Baseline, Day 7 (after treatment)
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Frontal-Vagal Activity via Heart Rate Deceleration (HRD)
大体时间：During each of the 28 iTBS sessions over the 7-day treatment period
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Heart rate data will be recorded using a Polar H10 sensor during iTBS sessions.
HRD will be calculated as the change in heart rate (beats per minute - bpm) during the stimulation period compared to the pre-stimulation baseline.
Lower heart rate (greater deceleration) is investigated as a predictor of higher fronto-vagal activation and treatment response.
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During each of the 28 iTBS sessions over the 7-day treatment period
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
脑电图的临床试验
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Ankara City Hospital Bilkent完全的
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Universitair Ziekenhuis BrusselAZ Sint-Jan AV尚未招聘
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