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
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 27, 2026
CompletedFirst Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
May 15, 2026
May 1, 2026
8 months
May 11, 2026
May 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
GLP level
0-2week
Study Arms (2)
Temporal Interference Stimulation
EXPERIMENTALTIS 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
PLACEBO COMPARATORThe stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm.
Interventions
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.
The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- /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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
Related Publications (1)
0
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Psychaitry, The First Affiliated Hospital of Zhejiang University School of Medicine
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 15, 2026
Study Start
April 27, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share