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

Shanghai Mental Health Center

Status: Enrolling

Conditions: Feeding and Eating Disorders

Treatments: Behavioral: cognitive behavior therapy; Device: Deep transcranial magnetic stimulation; Device: Sham deep transcranial magnetic stimulation; Other: Basic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06942858

82471573

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

CBT+dTMS treatment group

Experimental group

Description:

CBT+dTMS treatment group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention use real coils, targeting ACC, given 5 times per week (Monday to Friday) for 6 consecutive weeks.

Treatment:

Other: Basic treatment

Device: Deep transcranial magnetic stimulation

Behavioral: cognitive behavior therapy

CBT+pseudo-stimulation group

Active Comparator group

Description:

CBT+Pseudo-stimulation group has 55 patients. Each patient receives 12 individual sessions of CBT for 50 minutes 2 times per week for 6 weeks. dTMS intervention uses sham coils (with the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field). It is given 5 times per week (Monday to Friday) for 6 consecutive weeks.

Treatment:

Other: Basic treatment

Device: Sham deep transcranial magnetic stimulation

Behavioral: cognitive behavior therapy