RecruitingNot ApplicableNCT07589647

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

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

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

70 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder (BD)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria6

Both biological parents are of Han ethnicity;
Age range: 18 to 45 years old, gender not restricted;
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);
Body Mass Index (BMI) ≥ 28 kg/m2, or for males, waist circumference ≥ 90 cm and for females, waist circumference ≥ 85 cm;
HAMD-24 score < 7 points, YMRS score < 5 points;
All included researchers and their family members have given informed consent for this study.

Exclusion Criteria8

/5000
Individuals with other DSM-5 spectrum disorders;
Mental disorders caused by substance abuse (such as alcohol, drugs, etc.), and those with severe physical illnesses;
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;
Those currently having serious suicidal thoughts or behaviors, or those with severe agitation;
Those who cannot follow medical advice for treatment, or those without guardians;
Pregnant or lactating women, or those planning to become pregnant;
Those who cannot complete MRI examinations due to special conditions such as having metal implants or pacemakers in their bodies.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERTemporal Interference Stimulation

TIS treatment lasts for 20 minutes, with the maximum output current being 2mA, which is adjusted according to the individual head model. The two pairs of electrical stimulation frequencies in tTIS are 1000Hz and 1040Hz.

OTHERSham Temporal Interference Stimulation Arm Description

The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm.