Targeted brain stimulation to help metabolic issues in people with bipolar disorder and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will apply temporal interference stimulation to the suprachiasmatic nucleus in adults with bipolar disorder and obesity to observe changes in metabolic signals and circadian-related markers. The trial uses a sham control to compare effects and aims to understand potential molecular mechanisms behind metabolic disturbances. Participants will be adults aged 18 to 45 with stable bipolar disorder, BMI ≥ 28 kg/m2 (or larger waist measurements by sex), and low depression and mania scores. Outcomes include metabolic molecule changes such as GLP-1 and circadian rhythm markers, with safety monitored throughout. The study is conducted at the First Affiliated Hospital of Zhejiang University to explore whether this approach can stabilize metabolic and mood-related parameters.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Both biological parents are of Han ethnicity;
2. Age range: 18 to 45 years old, gender not restricted;
3. Meets the clinical diagnostic criteria for bipolar disorder as stipulated in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
4. Body Mass Index (BMI) ≥ 28 kg/m2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm;
5. HAMD-24 score \< 7 points, YMRS score \< 5 points;
6. All included researchers and their family members have given informed consent for this study.

Exclusion Criteria:

221/5000

1. Individuals with other DSM-5 spectrum disorders;
2. Mental disorders caused by substance abuse (such as alcohol, drugs, etc.), and those with severe physical illnesses;
3. Those who consumed food or microecological preparations containing probiotics, prebiotics, etc. within one week before enrollment, and had a history of respiratory, urinary, digestive system infections and antibiotic use within one month before enrollment;
4. Those currently having serious suicidal thoughts or behaviors, or those with severe agitation;
5. Those who cannot follow medical advice for treatment, or those without guardians;
6. Pregnant or lactating women, or those planning to become pregnant;
7. Those who cannot complete MRI examinations due to special conditions such as having metal implants or pacemakers in their bodies.

Where it's running

• First Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: ShaoHua Hu
• Email: dorhushaohua@zju.deu.cn
• Phone: 0571-87232984

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.