New treatment for anorexia nervosa using brain stimulation
A New Neuroregulatory Technology for the Therapy of AN Based on the Pathological Neural Network of ACC: A Multicenter Randomized Controlled Study
This study is testing if a new brain stimulation treatment can help adults with anorexia nervosa gain weight and improve their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06152640 on ClinicalTrials.gov |
What this trial studies
This research investigates the use of deep transcranial magnetic stimulation (dTMS) targeting the anterior cingulate cortex (ACC) as a novel intervention for adults with anorexia nervosa (AN). Participants will be randomly assigned to either the dTMS treatment group or a sham stimulation group, with a 28-day intervention followed by a six-month follow-up to assess efficacy and safety. The study aims to clarify the relationship between ACC activity and AN symptoms, utilizing fMRI data to develop a predictive model for treatment outcomes. The primary measure of success will be weight gain of at least 4 kg within four weeks post-treatment.
Who should consider this trial
Good fit: Ideal candidates are right-handed females aged 18-35 with a BMI between 13.0 and 18.5 who meet the diagnostic criteria for anorexia nervosa.
Not a fit: Patients with other psychiatric disorders, severe physical or cognitive impairments, or those at high risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals suffering from anorexia nervosa, potentially improving their weight and psychological health.
How similar studies have performed: While few studies have explored dTMS targeting the ACC for anorexia nervosa, similar neuroregulatory approaches have shown promise in treating other mental health conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Jue Chen — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jue Chen, PHD — Shanghai Mental Health Center
- Study coordinator: Jue Chen, PHD
- Email: chenjue2088@163.com
- Phone: +8618017311203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.