A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC
- Conditions
- Feeding and Eating Disorders
- Interventions
- Device: Deep transcranial magnetic stimulationDevice: Sham deep transcranial magnetic stimulationOther: Basic treatment
- Registration Number
- NCT06152640
- Lead Sponsor
- Shanghai Mental Health Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pseudo-stimulation group Basic treatment Pseudo-stimulation group has 40 patients with dTMS intervention using 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 once per day, for 28 days, with a total of 28 treatments. dTMS treatment group Deep transcranial magnetic stimulation dTMS treatment group has 40 patients with dTMS intervention using real coils, targeting ACC, given once per day, for 28 days, with a total of 28 treatments. dTMS treatment group Basic treatment dTMS treatment group has 40 patients with dTMS intervention using real coils, targeting ACC, given once per day, for 28 days, with a total of 28 treatments. pseudo-stimulation group Sham deep transcranial magnetic stimulation Pseudo-stimulation group has 40 patients with dTMS intervention using 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 once per day, for 28 days, with a total of 28 treatments.
- Primary Outcome Measures
Name Time Method Body Mass Index (BMI). whin 4 weeks after completion of treatment Calculation: BMI = weight (kg) divided by the square of height (m)
- Secondary Outcome Measures
Name Time Method 3.Beck Depression Inventory (BDI) baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment). The BDI consists of 21 items and assesses the patient's accompanying feelings of depression over the past 2 weeks.
4.Beck Anxiety Inventory (BAI) baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment). The BAI consists of 21 items and assesses the patient's accompanying feelings of anxiety over the past 1 week.
5. Self-assessed Compulsive Questionnaire for Eating Disorders (SR-YBC-EDS) baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment). The SR-YBC-EDS was developed based on the Yale-Brown Compulsive Questionnaire for Eating Disorders (YBC-EDS), consisting of two parts: the first part is a list of 65 symptomatic items, which is used to identify the subjects' obsessive-compulsive symptoms, and the second part is a list of 8 core items, which is used to assess the frequency and severity of obsessive-compulsive symptoms. All parts contain two dimensions: preoccupation and ritual behavior.
1.Eating Disorder Examination Questionnaire (EDE-Q6.0) baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment). Eating Disorder Examination Questionnaire can assess the core symptoms of eating disorders, including behavioral and psychological characteristics, and rate their frequency and intensity, which can assess the severity of the eating disorder. It consists of 4 subscales, including dietary restriction, eating concerns, body image concerns, and weight concerns.
2.Eating Disorder Inventory (EDI-II) baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 ( after completion of treatment). It is a commonly used scale for assessing cognitive-behavioral symptoms of eating disorders and is used to assess the severity of eating disorders. The scale contains 91 items divided into 8 subscales and 3 temporary subscales, including the pursuit of thinness, bulimia, body dissatisfaction, feelings of ineffectiveness, perfectionism, mistrust of others, introspection, maturity fears, abstinence, impulsive regulation and social insecurity.
6. Body Image Tasks baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment). Tasks that address excessive concerns about body shape/weight include the following two parts:
Body size estimation: The screen will present the above 30 body size pictures sequentially, the subjects will view the body size pictures in 4000ms, and then evaluate the body size of the body pictures in 4000ms, with a score of 1 representing "very low body weight", 4 representing "very overweight", and 4 representing "very overweight". A score of 1 represents "very low weight" and a score of 4 represents "very overweight".
Body compare task: The screen will present the above 30 body images in turn, the subjects will have 4000ms to view their own images (with randomized distortions), and then they will have 4000ms to compare their actual body shape with the body shape in the images and assess their emotional level. 1 point represents "very calm" and 4 for "very anxious".7. Delay Discounting Task (DDT task) baseline, day 28 (at the end of treatment), and weeks 4, 8, 12 and 24 (after completion of treatment). The study uses a DDT task in a food choice scenario to assess inhibitory impulses. The task requires subjects to make a decision between choosing a small reward in the present or a large reward in the future. Inhibition to choose a small reward in the present implies a strong intertemporal decision-making ability. The task begins with an assessment of their hunger, willingness to eat, and emotional feelings at the moment. Then they are asked to rate 40 pictures of food on a scale of 0 to 10 on five dimensions: familiarity, craving, positive and negative emotions, emotional intensity, and eating control. Pictures of foods with craving scores \>7 and eating control \<5, as well as matched in familiarity and emotion for use in the ensuing delay discounting task. The choice is made by pressing a button: Patients choosing to get less food immediately are given fewer coupons after the delay. But those waiting for a period of time to get more food are given more coupons after the delay.
Trial Locations
- Locations (1)
Jue Chen
🇨🇳Shanghai, Shanghai, China