Bipolar Disorder
Conditions
Interventions
True Stimulation Group:Stanford Neuromodulation Therapy (SNT) using accelerated intermittent theta burst stimulation (aiTBS) targeting the weakest functional connectivity site between left DLPFC and s
parameters: 90% RMT, 3 pulses per burst, 0.2 seconds inter-pulse interval, 10 bursts per session, 8 seconds inter-burst interval, repeated 60 times per treatment session
1800 pulses per session, 10 sessions per day, 50 minutes between sessions, continuous treatment for 5 days.
Sham Stimulation Group:Sham stimulation with coil reversed to a 90° angle relative to the scalp, matching appearance, stimulation frequency, and duration of the true stimulation group, but generating
Sponsors
The Sixth People's Hospital of Hebei Province
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Meets DSM-5 diagnostic criteria for Bipolar I or Bipolar II Disorder; 2. Aged 18–60 years, either sex; 3. Stable pharmacotherapy (valproate or quetiapine) for at least 4 weeks prior to enrollment; 4. Montgomery-Åsberg Depression Rating Scale (MADRS) score >=20 and Young Mania Rating Scale (YMRS) score <6; 5. Right-handed; 6. Normal intelligence, educational level of primary school or above, Han Chinese ethnicity.
Exclusion criteria
Exclusion criteria: 1. Meets DSM-5 diagnostic criteria for other mental disorders; 2. Diagnosed neurological disorders (e.g., epilepsy); history of brain organic disease or severe traumatic brain injury; severe or unstable physical illness; 3. Contraindications for fMRI or rTMS; 4. Received modified electroconvulsive therapy (MECT) or light therapy within the past 3 months; 5. Prior antidepressant treatment involving implanted devices; 6. Pregnant or lactating women; 7. Speech communication difficulties precluding cooperation with treatment and assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MADRS score from baseline to end of SNT treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in MADRS, HAMA, CGI, and THINC-it scores at end of treatment and follow-up period;Response rate;Remission rate;Electroencephalographic microstate parameters (duration, occurrence rate, coverage, transition rate);Global explained variance (GEV) of EEG microstates; | — |
Countries
China
Contacts
Public ContactXu Haoran
The Sixth People's Hospital of Hebei Province
Outcome results
None listed