Clinical trial NCT06152640: A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC
Official title: A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC: A Multicenter Randomized Controlled Study
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
Collaborators: name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Huadong Hospital
name: Shanghai University of Traditional Chinese Medicine
First posted: 2023-12-01
Enrollment: 80
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: 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.

Detailed 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.

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.

Primary outcomes:
measure: Body Mass Index (BMI).
timeFrame: whin 4 weeks after completion of treatment
Secondary outcomes:
measure: 1.Eating Disorder Examination Questionnaire (EDE-Q6.0)
timeFrame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
measure: 2.Eating Disorder Inventory (EDI-II)
timeFrame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
measure: 3.Beck Depression Inventory (BDI)
timeFrame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
measure: 4.Beck Anxiety Inventory (BAI)
timeFrame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
measure: 5. Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS)
timeFrame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment).
measure: 6. Body Image Tasks
timeFrame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment).
measure: 7. Delay Discounting Task (DDT task)
timeFrame: baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jue Chen
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jue Chen, PHD
role: PRINCIPAL_INVESTIGATOR
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