Clinical trial NCT06516991: Task-State-Based Temporal Interference Stimulation (TI) to Improve Depression in Patients With Bipolar Disorder
Official title: Efficacy and Safety of Task-State-Based Temporal Interference Stimulation (TI) in Improving Depression in Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Depression
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 of TI in bipolar disorder depressive episodes based on task state MRI scanning, and to explore the abnormal regulation mechanism of anhedonia neural circuit.


Eligibility criteria: Inclusion Criteria:

1. Aged 16-50 years, right-handed, and completed nine years of compulsory education;
2. Meet the diagnostic criteria for bipolar disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
3. HAMD-17: \>17 points , assessed the presence of rapture deficits;
4. Subject had not been treated with a mood stabilizer, or had previously used an antidepressants and currently off medication for ≥1 week;
5. 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 Criteria:

1. Co-morbid other psychiatric disorders, including affective psychiatric disorders, anxiety spectrum disorders, mental retardation, substance dependence (abuse), etc.;
2. History of a serious physical illness or a disease that may affect the central nervous system;
3. 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;
4. 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);
5. 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;
6. Pregnant and lactating women, and women of childbearing age with positive urine pregnancy.

Primary outcomes:
measure: Hamilton Depression Scale（HAMD-17)
timeFrame: 0-5 days
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale（MADRS）
timeFrame: 0-5 days
measure: Hamilton Anxiety Scale（HAMA）
timeFrame: 0-5 days
measure: Young Mania Rating Scale（YMRS）
timeFrame: 0-5 days
measure: Snaith-Hamilton Pleasure Scale（SHAPS）
timeFrame: 0-5 days
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: 0-5 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: