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Research on the Efficacy and Safety of Targeted Suprachiasmatic Nucleus Electrical Stimulation for Improving Metabolic Disorders in Patients With Stable Bipolar Disorder Comorbid With Obesity

RecruitingNAAges 18 Years - 45 YearsAllFirst Affiliated Hospital of Zhejiang University
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In plain words

What the trial is, and whether it could suit you

This study aims to stabilize the patients with bipolar disorder (BD) comorbid with obesity in the stable phase by using temporal interference stimulation (TIS ) intervention. It intends to investigate the changes in key metabolic molecules such as GLP-1 circadian rhythm, and further explore the molecular mechanism of their metabolic disorders.

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๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ 28 kg/m2, or for males, waist circumference โ‰ฅ 90 cm and for females, waist circumference โ‰ฅ 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.
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What it tests

  • Temporal Interference Stimulation
  • Sham Temporal Interference Stimulation Arm Description
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Where

1 site
First Affiliated Hospital of Zhejiang University
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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