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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Temporal Interference Stimulation
Other interventionTIS 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 interventionThe stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters werethe same as the Active Comparator arm.
Treatment groups
Trial outcomes
Primary outcomes
GLP level
Sponsors and contacts
Click on the lead sponsor to view all of their trials.