Actively Recruiting
Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression: a Randomized Controlled Study
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-05-27
160
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of temporal interference stimulation, a non-invasive brain stimulation method, to improve symptoms of bipolar depression. The study also aims to explore related brain activity changes using magnetic resonance imaging and electroencephalogram, which may help develop new treatment approaches and objective ways to predict treatment effects in bipolar disorder. Participants will be randomly assigned to receive either active temporal interference stimulation or a sham version that mimics the sensation without real stimulation. The treatment involves delivering high-frequency electrical fields to the brain. The study uses a double-blind design, meaning neither participants nor researchers know who receives real or sham stimulation during the treatment. During the study, participants will be assessed using several depression and anxiety rating scales, including the Montgomery-Asberg Depression Rating Scale at baseline, day 5, and multiple follow-ups up to 4 weeks after treatment. Other evaluations include mania, pleasure experience, depressive symptoms, anxiety levels, and cognitive function tests. Safety and efficacy will be closely monitored throughout the study period, which runs until December 2026.
CONDITIONS
Brief Title
Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Right-handed and have completed nine years of compulsory education
- Meet the DSM-5 criteria for bipolar depression
- Score 18 or higher on the Hamilton Depression Inventory (HAMD-17)
- Score 8 or lower on the Young Mania Rating Scale (YMRS)
- No psychiatric medication treatment or completed medication washout at least 2 weeks before randomization
- Willing to cooperate with treatment and sign informed consent after understanding Temporal Interference Stimulation (TI)
You will not qualify if you...
- Contraindications to MRI or temporal interference stimulation, such as having metallic or electronic devices in the body (e.g., intracranial metal, cochlear implants, pacemakers, stents)
- History of electroconvulsive therapy (ECT), modified ECT, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation
- Pregnant or breastfeeding women, or women of childbearing age with a positive pregnancy test
- Diagnosed with another major psychiatric disorder causing more impairment than bipolar disorder
- Coexisting psychiatric disorders such as obsessive-compulsive disorder, personality disorders, anxiety spectrum disorders, intellectual disability, or substance dependence
- Active suicidal thoughts with a score of 4 or higher on item 10 of the MADRS
- Risk of serious harm to self or others
- History of serious physical illness affecting the central nervous system
- Risk factors for neurological disorders or seizures, such as cranial trauma, abnormal EEG, brain structural abnormalities on MRI, or family history of epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive temporal interference stimulation or a sham version as part of the study intervention to improve bipolar depression.
Daily visits for 5 consecutive days (in-person)
Duration - 4 weeks
Participants are monitored for safety and efficacy outcomes after the end of stimulation.
Visits at 1 week, 2 weeks, and 4 weeks after the end of stimulation (in-person)
Trial Site Locations
Total: 1 location
1
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
S
Shaohua Hu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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