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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sarp Yoldas, MD
- 電話番号：+905069898506
- メール：sarpyoldas@gmail.com
研究場所
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Bakirkoy
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Istanbul、Bakirkoy、トルコ（Türkiye）、34153
- 募集
- Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi
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コンタクト：
- Sarp Yoldas, MD
- 電話番号：+905069898506
- メール：sarpyoldas@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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EEG Microstate Analysis Parameters
時間枠：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)
時間枠：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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1395891
- 38661 (その他の助成金/資金番号：İstanbul Üniversitesi-Cerrahpaşa Rektörlüğü, Bilimsel Araştırma Projeleri)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
脳波の臨床試験
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Zhiyi ZuoSun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityわからない
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University of ChileCenter for Advanced Clinical Research (CICA ) - University of Chileまだ募集していません麻酔からの覚醒 | EEGパワースペクトル
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All India Institute of Medical Sciences, New Delhiわからない
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Istanbul Medipol University HospitalScientific and Technological Research Council of Turkey (TÜBİTAK)完了
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Kocaeli University積極的、募集していない
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Chang Gung Memorial HospitalAleddra, Inc.募集
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Ankara City Hospital Bilkent完了鎮静を伴う DISE 処置中に 4 チャンネル EEG を使用する利点を確認するトルコ（Türkiye）
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Istanbul University募集全静脈麻酔 | 脊椎（融合）手術 | プロポフォールの標的制御注入 | Bis-eeg | 麻酔深度モニタリングトルコ（Türkiye）
iTBS TMSの臨床試験
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Mclean HospitalMassachusetts General Hospital完了
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Wake Forest University Health Sciences募集
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University of California, San DiegoNational Institutes of Health (NIH)完了
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The Second Affiliated Hospital of Kunming Medical...まだ募集していません
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)募集
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Danderyd HospitalKarolinska Institutet募集
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Danderyd HospitalKarolinska Institutet募集