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

NCT ID: NCT06942858

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2028-12-31

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.

Conditions

Feeding and Eating Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT+dTMS treatment group

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.

Group Type: EXPERIMENTAL

Deep transcranial magnetic stimulation

Intervention Type: DEVICE

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. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.

cognitive behavior therapy

Intervention Type: BEHAVIORAL

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.

Basic treatment

Intervention Type: OTHER

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.

CBT+pseudo-stimulation group

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.

Group Type: ACTIVE_COMPARATOR

cognitive behavior therapy

Intervention Type: BEHAVIORAL

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.

Sham deep transcranial magnetic stimulation

Intervention Type: DEVICE

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 week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.

Basic treatment

Intervention Type: OTHER

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.

Interventions

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. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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 week (Monday to Friday) for 6 consecutive weeks. Intervention mode: stimulation frequency 20Hz, stimulation intensity 100% RMT, number of serial pulses 50, sequence interval 20s, a total of 40 trials, 2000 pulses, stimulating the left and right ACC respectively.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Jue CHEN

Director of Psychosomatic Department in Shanghai Mental Health Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jue Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jue Chen, PHD

Role: CONTACT

chenjue2088@163.com

+8618017311203

Facility Contacts

Jue Chen, PHD

Role: primary

chenjue2088@163.com

+8618017311203

Other Identifiers

82471573

Identifier Type: -

Identifier Source: org_study_id