Bipolar Disorder (BD)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
A study testing Temporal Interference Stimulation in people with Bipolar Disorder (BD), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bipolar Disorder (BD)
- What is being tested?
- Temporal Interference Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official 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
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.
- Conditions
- Bipolar Disorder (BD)
- Being tested
- Temporal Interference Stimulation, Sham Temporal Interference Stimulation Arm Description
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference StimulationOther
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 DescriptionOther
The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation | Experimental | 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. Receives: Other: Temporal Interference Stimulation |
| Sham Temporal Interference Stimulation | Placebo comparator | The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm. Receives: Other: Sham Temporal Interference Stimulation Arm Description |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP level
Measured: 0-2week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start27 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589647
- Sponsor's protocol ID
- IIT20260026C-R1
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
0
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07589647
- Acronym / sponsor ID
- IIT20260026C-R1
- Conditions
- Bipolar Disorder (BD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Other: Temporal Interference StimulationTIS 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 comparator | Other: Sham Temporal Interference Stimulation Arm DescriptionThe stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal Interference StimulationTIS 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 |
| Sham Temporal Interference Stimulation Arm DescriptionThe 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 |
Primary outcome
GLP level
Time frame: 0-2week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background0
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference Stimulation in people with Bipolar Disorder (BD), run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ShaoHua Hu (0571-87232984, dorhushaohua@zju.deu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLP level (time frame: 0-2week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.