Status:
COMPLETED
Task-State-Based Temporal Interference Stimulation (TI) to Improve Depression in Patients With Bipolar Disorder
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Bipolar Depression
Eligibility:
All Genders
16-38 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the efficacy and safety of temporal interference stimulation (TI) in improving depressive episodes of bipolar disorder, to analyze the therapeutic principle...
Eligibility Criteria
Inclusion
- Aged 16-50 years, right-handed, and completed nine years of compulsory education;
- Meet the diagnostic criteria for bipolar disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- HAMD-17: \>17 points , assessed the presence of rapture deficits;
- Subject had not been treated with a mood stabilizer, or had previously used an antidepressants and currently off medication for ≥1 week;
- The subject/legal guardian is willing to actively cooperate with the treatment and sign an informed consent form after being fully informed of the temporal interference stimulus (TI).
Exclusion
- Co-morbid other psychiatric disorders, including affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
- History of a serious physical illness or a disease that may affect the central nervous system;
- Neurologic disorders or risk of seizures such as previous cranial disorders, head trauma, abnormal electroencephalograms, magnetic resonance evidence of structural brain abnormalities, or a family history of epilepsy;
- Contraindications to magnetic resonance scanning or time-interference stimulation (TI), such as the presence of metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies);
- Those who have received or are receiving electroconvulsive therapy (ECT ), modified electroconvulsive therapy (MECT ), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments;
- Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.
Key Trial Info
Start Date :
July 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06516991
Start Date
July 16 2024
End Date
September 30 2024
Last Update
April 6 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000