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

Feeding and Eating Disorders Clinical Trial

Official title: A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC: A Multicenter Randomized Controlled Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Building on the previous foundation and literature review, we found that ACC is closely related to the core symptoms of AN, and proposed the hypothesis of "AN-ACC pathological network", suggesting that ACC overactivation and abnormal functional connectivity with other brain regions (anterior frontal lobe, parietal lobe, precuneus, and striatum) 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 a 28-day intervention (once a day) and 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. Efficacy is judged by a weight gain of 4 kg in the four weeks following the intervention. Symptoms, psychometrics and side effect questionnaires are followed up at baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment). Meanwhile, baseline fMRI data will be extracted and combined with clinical features to establish an efficacy prediction model. We will explore factors predictive of dTMS efficacy in AN patients of dTMS treatment group, divided into two groups according to whether dTMS is effective or not after treatment (defined as a weight gain of 4 kg in the four weeks following the intervention), using pre-treatment (baseline) demographic information, psychological assessment questionnaires, and neuroimaging data in the two groups. This 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. ;

Related Conditions & MeSH terms

• Feeding and Eating Disorders

• NCT number: NCT06152640
• Study type: Interventional
• Source: Shanghai Mental Health Center
• Contact: Jue Chen, PHD
• Phone: +8618017311203
• Email: chenjue2088@163.com
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Completion date: May 31, 2026