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Идёт набор NCT06692114

Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of OCD

Без фазы С лечением Obsessive-Compulsive Disorder

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: Deep Transcranial Magnetic Stimulation, DTMS active, Deep Transcranial Magnetic Stimulation, DTMS sham.
Кому может быть актуально
Состояния в реестре: Obsessive-Compulsive Disorder. Базовые параметры: 18 лет — 50 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
Китай
Следующий шаг
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Официальное название

A Preliminary Study on the Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of Obsessive-compulsive Disorder

Обзор

This study aims to explore the efficacy and influencing of accelerated dTMS (deep Transcranial Magnetic Stimulation) treatment in patients with obsessive-compulsive disorder (OCD), and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).

Подробное описание

The study is to recruit eligible patients with obsessive-compulsive disorder (OCD) from the Shanghai Mental Health Center for deep transcranial magnetic stimulation (dTMS) intervention, and recruit healthy controls who meet the enrollment criteria from the community. Among them, patients with OCD will be randomly divided into a real stimulation group and a sham stimulation group. After baseline assessment, dTMS treatment will be administered twice a day. EEG data collection, MRI data, cognitive tasks, psychological self-assessment scales and clinical symptom assessment will be conducted before treatment and 2 weeks after treatment. During the treatment process, patients will receive two treatments per day, each lasting 20 minutes, for a total of 2 weeks, or 28 treatments in total.

Вмешательства

  • Устройство Deep Transcranial Magnetic Stimulation, DTMS active
    The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Each treatment stimulates at a frequency of 20 Hz for 2 seconds, with a sequence interval of 20 seconds. Each treatment consists of 50 sequences, for a total of 2000 pulses.
  • Устройство Deep Transcranial Magnetic Stimulation, DTMS sham
    The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Compared with active treatment, the sham stimulation coil only produced sound and scalp vibration.

Первичные конечные точки

  • To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD [Срок оценки: baseline,2weeks,4weeks]
Вторичные конечные точки (3)
  • To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD [Срок оценки: baseline,2 weeks, 4 weeks]
  • Change in The Beck Depression Inventory (BDI) [Срок оценки: baseline,2 weeks, 4 weeks]
  • Change in the The Beck Anxiety Inventory (BAI) [Срок оценки: baseline,2 weeks, 4 weeks]

Критерии участия

Критерии включения

  • Aged between 18 and 50, both genders are welcome.
  • DSM-5 criteria for OCD.
  • Y-BOCS total score ≥ 20 despite therapeutic-dose SRI treatment or completion of at least one full course of CBT. The treatment regimen must have been stable for at least 8 weeks prior to enrollment and remain unchanged throughout the study.
  • More than 9 years of education.
  • Right-handed.

Критерии исключения

  • Any additional current psychiatric comorbidity, except for obsessive- compulsive personality disorder.
  • Severe obsessive symptoms prevent the completion of necessary assessments.
  • Has a history of receiving ECT therapy.
  • Has received rTMS or tDCS treatment within the past two months.
  • Has severe physical illnesses or any physical conditions that can induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, among others.
  • Has a past history of neurological disorders (such as epilepsy, cerebrovascular accidents, etc.) or brain injuries, or a history of brain surgery.
  • Has implanted medical devices such as intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, etc.
  • Serious suicide risk.
  • Pregnancy or nursing of an infant.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT06692114 · SMHC-OCD-012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗