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RecruitingNCT07589647Updated May 27, 2026

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

An interventional study of Temporal Interference Stimulation and Sham Temporal Interference Stimulation Arm Description in Bipolar Disorder (BD), sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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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.

02

Conditions studied

  • Bipolar Disorder (BD)

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03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's planned enrollment of 70 is close to the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Temporal Interference Stimulation

  • Placebo comparator
    Sham Temporal Interference Stimulation

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

    Other: Sham Temporal Interference Stimulation Arm Description

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.

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What researchers measure

Primary outcomes

  1. GLP level

    Time frame: 0-2week

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Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Zhejiang University
    Hangzhou, Zhejiang 310003, China
    Recruiting
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References and documents

Publications

  • 0

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07589647
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Hu ShaoHua (Department of Psychaitry, The First Affiliated Hospital of Zhejiang University School of Medicine, First Affiliated Hospital of Zhejiang University) — Principal investigator
First posted
May 15, 2026
Start date
Apr 27, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
May 27, 2026

Study contacts

ShaoHua Hu
Contact
dorhushaohua@zju.deu.cn
0571-87232984

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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