A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC

Summary

Hypothesis of "AN-ACC pathological network" suggests that ACC overactivation and abnormal functional connectivity with other brain regions is the neuropathological mechanism for the onset of AN. Currently, rare studies have been conducted on dTMS targeting ACC as an intervention in patients with AN. In this research, dTMS, a neuroregulatory technology, is used for the first time to intervene with ACC in the treatment of adult AN. A randomized controlled study design is adopted, in which patients with AN are divided into the dTMS treatment group and the pseudo-stimulation group by 1:1 randomization, followed by 6-week intervention and half-year follow up, to clarify the near-term and long-term efficacy and safety of the dTMS treatment. Meanwhile, baseline fMRI data will be extracted and combined with clinical features to establish an efficacy prediction model, which will provide theoretical and practical basis for the pioneering ACC-targeted dTMS treatment in China, helping to establish a new type of intervention program for AN, with expected results of innovation.

Conditions

• Feeding and Eating Disorders

Interventions

DEVICE

Deep transcranial magnetic stimulation

Neuronavigation: The coil is positioned 4cm in front of the scalp point and foot motor cortex, corresponding to the ACC. The Brainways H7 coil with fluid cooling is used to obtain a greater depth of stimulation, up to about 6 cm below the cortex. dTMS intervention: The intervention targets are at the left and right ACC, once per day, for 28 days. A total of 28 treatments are given. Stimulation mode: stimulation frequency 1Hz, stimulation intensity 100% RMT, number of pulses 150, sequence interval 20s, total 6 trials, 900 pulses.

DEVICE

Sham deep transcranial magnetic stimulation

Neuronavigation: The sham coil is positioned 4 cm in front of the scalp point and foot motor cortex, corresponding to the ACC. Sham dTMS intervention: The intervention targets are at the left and right ACC (The sham coil has the same parameters as real dTMS and generating the same noise as real coils, but without the magnetic field), once per day, for 28 days. A total of 28 treatments are given.

OTHER

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.

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine

  collaborator OTHER

• Huadong Hospital

  collaborator OTHER

• Shanghai University of Traditional Chinese Medicine

  collaborator OTHER

• Shanghai Mental Health Center

  lead OTHER

Principal Investigators

• Jue Chen, PHD · Shanghai Mental Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-30

Primary Completion

2025-12-31

Completion

2026-05-31

Countries

• China

Study Locations