Clinical trial NCT06942858: Mechanisms of Deep Transcranial Magnetic Stimulation in Enhancing Cognitive-Behavioral Therapy for Anorexia Nervosa
Official title: Mechanisms of Deep Transcranial Magnetic Stimulation Enhances the Efficacy of Cognitive-behavioral Therapy (CBT) by Modulating Anterior Cingulate Cortex in Patients With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Feeding and Eating Disorders
Keywords: anorexia nervosa
Deep transcranial magnetic stimulation
anterior cingulate cortex
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q6.0)
timeFrame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
measure: Eating Disorder Inventory (EDI-II)
timeFrame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
measure: Beck Depression Inventory (BDI)
timeFrame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
measure: Beck Anxiety Inventory (BAI)
timeFrame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
measure: Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS)
timeFrame: week 0（baseline）, week 2、week4（during intervention）, week 6（post-intervention）, week10、18、30（follow-up）
measure: Body Image Tasks
timeFrame: week 0（baseline）, ,week 6（post-intervention）
measure: Delay Discounting Task (DDT task)
timeFrame: week 0（baseline）, week 6（post-intervention）
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jue Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References: