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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Temporal Interference Stimulation
  • Sham Temporal Interference Stimulation Arm Description

Treatment groups

70 Participants
are divided into 2 treatment groups