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Clinical Trials in China / NCT07589647
Recruiting Not applicable

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

NCT07589647 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Zhejiang University
Phase
Not applicable
Started
2026-04-27
Last updated
2026-05-27

Condition(s) studied

Bipolar Disorder (BD)

Investigational drug(s) / intervention(s)

Temporal Interference StimulationSham Temporal Interference Stimulation Arm Description

Temporal 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.

Sham 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang Recruiting

More First Affiliated Hospital of Zhejiang University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07589647 on ClinicalTrials.gov ↗ ← All trials in China