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NCT Number: NCT07589647

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

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

221/5000

  • 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.

Treatment and study plan

Temporal Interference Stimulation

Other

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

Other

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

Primary outcomes

  1. GLP level

    Time frame: 0-2week

Study contacts

Contact information is provided by the study sponsor or research team.

ShaoHua Hu

CONTACT

[email protected]

0571-87232984

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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