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Идёт набор NCT07561528

Electrophysiological Biomarkers and Treatment Response to Accelerated Transcranial Magnetic Stimulation in Patients With Obsessive-Compulsive Disorder

Без фазы С лечением Obsessive - Compulsive Disorder Transcranial Magnetic Stimilation Intermittent Theta Burst Stimulation EEG

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: iTBS TMS.
Кому может быть актуально
Состояния в реестре: Obsessive - Compulsive Disorder, Transcranial Magnetic Stimilation, Intermittent Theta Burst Stimulation, EEG. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Investigation of the Relationship Between Electrophysiological Biomarkers and Treatment Response in Patients Diagnosed With Obsessive-Compulsive Disorder Undergoing Transcranial Magnetic Stimulation Therapy

Обзор

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.

Вмешательства

  • Устройство iTBS TMS
    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

Первичные конечные точки

  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Total Score [Срок оценки: 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)"]
Вторичные конечные точки (2)
  • EEG Microstate Analysis Parameters [Срок оценки: Baseline, Day 7 (after treatment)]
  • Frontal-Vagal Activity via Heart Rate Deceleration (HRD) [Срок оценки: During each of the 28 iTBS sessions over the 7-day treatment period]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Cerrahpaşa Tıp Fakültesi Prof. Dr. Murat Dilmener Hastanesi — Istanbul

Публикации

  • McGirr A, Cole J, Patten SB, Adams B. Intermittent Theta Burst Stimulation With Adjunctive D-Cycloserine for Obsessive-Compulsive Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2025 Mar 1;182(3):307-311. doi: 10.1176/appi.ajp.20240181. Epub 2025 Feb 19. No abstract available. PMID 39967412

Идентификаторы

NCT: NCT07561528 · 1395891 · 38661

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗