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Validation and application of a new clinical technique for the treatment of bipolar disorder with 77.5 Hz transcranial alternating current stimulation

Validation and application of a new clinical technique for the treatment of bipolar disorder with 77.5 Hz transcranial alternating current stimulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085488
Enrollment
Unknown
Registered
2024-06-07
Start date
2024-06-27
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder is a chronic condition that affects the functioning of the brain and, as a serious mental illness, is characterized by significant fluctuations in mood, energy levels, and behavior, and these fluctuations are usually manifested in two main phases: a manic (or hypomanic) phase and a depressive phase. These mood swings are not ordinary mood ups and downs, but rather extreme emotiona

Interventions

77.5Hz-tACS group:77.5Hz-tACS treatment
sham 77.5Hz-tACS group:sham 77.5Hz-tACS treatment

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Be between 18 and 60 years of age; 2. Diagnosed with bipolar disorder type I or II in accordance with the diagnostic criteria of the U.S. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) or ICD-10; 3. Have experienced at least one manic or hypomanic episode and one depressive episode in the past 12 months; 4. Not experiencing severe psychotic symptoms (e.g., hallucinations or delusions) for at least 6 months prior to enrollment; 5.The patient's physical examination, medical history, vital signs, blood, urine and stool routines, liver and kidney function, electrolytes, electrocardiogram, electroencephalogram and other indicators are normal; 6.After fully understanding the safety of transcranial alternating current stimulation (tACS), the patient is willing to actively cooperate with the treatment, and the patient and his/her family members sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Age 60 years; 2. History of serious physical illness; 3. Patients with metallic or electronic instruments placed in the body, such as intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies; 4. Those at risk for seizures, with a history of craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or a family history of epilepsy; 5. Those with psychotic symptoms requiring a combination of should antipsychotic medications; 6. Receiving other physical therapy after enrollment; 7. Those who are pregnant, breastfeeding, or planning to become pregnant during the trial; 8. Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Clinical Scale Assessment;

Secondary

MeasureTime frame
Electromyographic changes;EEG changes;Near infrared functional imaging;nuclear magnetic;Behavioral tasks;

Countries

China

Contacts

Public ContactDongsheng Zhou

Affiliated Kangning Hospital of Ningbo University

wyzhouds@sina.com+86 574 26302565

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026