Mechanisms of Deep Transcranial Magnetic Stimulation in Enhancing Cognitive-Behavioral Therapy for Anorexia Nervosa

Официальное название

Mechanisms of Deep Transcranial Magnetic Stimulation Enhances the Efficacy of Cognitive-behavioral Therapy (CBT) by Modulating Anterior Cingulate Cortex in Patients With Anorexia Nervosa

Обзор

The goal of this clinical trial is to learn if dTMS targeting the ACC can be used to rapidly and effectively treat AN. A randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by a 6-week intervention and a half-year follow-up to clarify whether CBT combined with dTMS is superior to single CBT treatment for AN.

Подробное описание

The investigators propose hypothesis that CBT improves AN symptoms by modulating the "AN-ACC pathology network", and that high-frequency stimulation targeting the ACC by dTMS can synergize "AN-ACC pathology network" and enhance the efficacy of CBT. In order to verify this hypothesis, a randomized controlled study design is adopted, in which patients with AN are divided into the CBT+dTMS treatment group and CBT+pseudostimulation group by 1:1 randomization, followed by 6-week intervention and a half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Patients in both groups undergo fMRI examinations, complete delay discounting task (DDT) and body image task before and after each treatment session. Symptoms, psychometrics and side effect questionnaires are followed up at baseline, week 6 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment). This study will provide a theoretical and practical basis for the innovative combined intervention method in patients with AN, and to verify the "AN-ACC pathological network" pathomechanism of AN at multiple levels.

Вмешательства

• Устройство Deep transcranial magnetic stimulation
  M-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC. A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The coil is an integrated coil for true and false stimulation loops. The intervention protocol is as follows: 30 treatments are given 5 times per week (Monday to Friday) for 6 consecutive weeks. Interventio
• Поведенческое cognitive behavior therapy
  Each patient receives 12 individual sessions of 50 minutes twice a week for 6 weeks.The CBT therapists are nationally registered psychotherapists with systematic professional training and uniform training in CBT for anorexia nervosa to ensure consistency. They are also supervised by a CBT supervisor at the end of each session.
• Устройство Sham deep transcranial magnetic stimulation
  M-100 Ultimate pulsed magnetic field stimulator is used for dTMS treatment. The coil is positioned 4 cm anterior to the scalp point and the foot motor cortex, corresponding to the ACC (The sham coil has the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). A naturally cold HF001A coil is used to obtain a greater depth of stimulation, up to about 6 cm subcortical. The intervention protocol is as follows: 30 treatments are given 5 times per
• Другое Basic treatment
  According to national and international guidelines for the treatment of eating disorders, the basic treatment for patients is nutritional therapy, that is, regular and quantitative dietary treatment, with three regular meals followed by a snack meal 2 hours after the regular meal. Both groups received the same nutritional treatment.

Первичные конечные точки

• Body Mass Index (BMI) [Срок оценки: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）]

Вторичные конечные точки (7)

• Eating Disorder Examination Questionnaire (EDE-Q6.0) [Срок оценки: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）]
• Eating Disorder Inventory (EDI-II) [Срок оценки: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）]
• Beck Depression Inventory (BDI) [Срок оценки: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）]
• Beck Anxiety Inventory (BAI) [Срок оценки: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）]
• Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS) [Срок оценки: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）]
• Body Image Tasks [Срок оценки: week 0（baseline）, ,week 6（post-intervention）]
• Delay Discounting Task (DDT task) [Срок оценки: week 0（baseline）, week 6（post-intervention）]

Критерии участия

Критерии включения

• Inclusion Criteria:
• Female, aged 18-35 years, right handedness.
• Above primary education.
• Meet the diagnostic criteria of AN in DSM-V, and13.0 kg/m2 ≤ body mass index (BMI)<18.5 kg/m2.
• No systemic nutritional therapy, psychiatric medication or any form of psychotherapy have been received within 1 month before enrollment.
• Able to understand the nature of this study and sign an informed consent form.

Критерии исключения

• Diagnosed with a DSM-5 disease other than anorexia nervosa, or at high risk of suicide, strong impulsive behavior as well as anti-social behavior.
• With severe physical or cognitive impairment.
• Not able to undergo MRI.
• Considered unsuitable for enrollment in this clinical trial for other reasons.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mental Health — Шанхай

Идентификаторы

NCT: NCT06942858 · 82471573

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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