Using deep transcranial magnetic stimulation to enhance therapy for anorexia nervosa
Mechanisms of Deep Transcranial Magnetic Stimulation Enhances the Efficacy of Cognitive-behavioral Therapy (CBT) by Modulating Anterior Cingulate Cortex in Patients With Anorexia Nervosa
NA · Shanghai Mental Health Center · NCT06942858
This study is testing if adding a special brain stimulation treatment to therapy can help people with anorexia nervosa feel better and improve their recovery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Shanghai Mental Health Center (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06942858 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the effectiveness of deep transcranial magnetic stimulation (dTMS) targeting the anterior cingulate cortex (ACC) in conjunction with cognitive-behavioral therapy (CBT) for treating anorexia nervosa (AN). Participants will be randomly assigned to either the CBT+dTMS group or a control group receiving CBT with pseudostimulation. The study will involve a 6-week intervention period followed by a half-year follow-up to assess both immediate and long-term outcomes. Patients will undergo various assessments, including fMRI scans and psychometric evaluations, to measure the efficacy and safety of the combined treatment approach.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-35 with a diagnosis of anorexia nervosa and a BMI between 13.0 kg/m2 and 18.5 kg/m2.
Not a fit: Patients with other psychiatric disorders, severe cognitive impairments, or those at high risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with anorexia nervosa.
How similar studies have performed: While the combination of dTMS and CBT is a novel approach, previous studies have shown promise in using dTMS for various psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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
- Shanghai Mental Health — 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.
Conditions: Feeding and Eating Disorders, anorexia nervosa, Deep transcranial magnetic stimulation, anterior cingulate cortex