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Effectiveness of Transcranial Strong Alternating Current Stimulation in the Treatment of Bipolar Disorder - A Randomized Double-blind Controlled Study

Effectiveness of Transcranial Strong Alternating Current Stimulation in the Treatment of Bipolar Disorder - A Randomized Double-blind Controlled Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099968
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-03
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Bipolar Disorder

Interventions

Sponsors

Beijing HuiLongGuan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 12-65 years old; 1.No gender limit; 2.Meet the DSM-V diagnostic criteria for bipolar disorder, currently in a state of depression (HAMD-17 >= 7 points) and/or anxiety (HAMA >= 14 points), and not in mania or in hypomanic state (YMAS<=5 points); 3.Within 12 weeks before screening, the patient's psychiatric drug treatment plan is stable, and the types and doses of psychiatric drugs used within 4 weeks of the planned treatment period do not need to be adjusted; 4.Literacy of at least junior high school and sufficient to understand the content of neuropsychological tests; 5.The patient volunteered to participate in this study, and he/she and/or his/her guardian signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Intellectual disability; 2.Previous or current organic brain diseases or severe unstable physical diseases, unable to complete the study; 3.Have been diagnosed of schizophrenia, schizoaffective disorder or other mental disorders associated with diseases; 4.Drug, alcohol or other psychoactive substance abusers within the past 3 months; 5.Have aggressive behavior, or high suicidal risk; 6.Pregnant and lactating women; 7.A history of epilepsy,except for febrile convulsions; 8.Have alcohol/drug dependence or acute poisoning within 1 year; 9.Those who are severely excited, restless, restless, and unable to maintain a state of meditation; 10.Currently (or in the last 4 weeks) taking more than 2 mg daily (or equivalent) of lorazepam or any dose of medication for seizures; 11.With history of craniocerebral injury or nervous system or repeated episodes of headache; 12.Allergies to alcohol, adhesive tape, conductive paste, and metal electrodes; 13.Have metal objects embedded in the body can not be removed, such as dentures, artery clips, pacemakers or metal fixtures, etc; 14.Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination; 15.Have participated in other pharmaceutical clinical trials in the last month; 16.Receive modified electroconvulsive treatment (MECT) in the last month; 17.Participated in other relevant investigators in the last month; 18.Participants who are deemed unsuitable by the researchers to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Depression Severity: Clinician-rated scale;Depression Severity: Self-rated scale;Severity of cognitive impairment;

Secondary

MeasureTime frame
Imaging indicators;EEG activity;Bipolar Severity: Clinician-rated scale;Anxiety Severity: Clinician-rated scale;Mania Severity: Clinician-rated scale;Deficits in social functioning: Clinician-rated scale;Impulsiveness and inhibition ability;Quality of sleep disturbances: Self-rated scale;Anxiety severity: Self-rated scale;Traumatic situations in childhood: Self-rated scale;Suicidal ideation severity: Self-rated scale;Dynamic Visual Attention Tracking Capability;Attentional Control and Executive Function;

Countries

China

Contacts

Public ContactHu Deng

Beijing HuiLongGuan Hospital

denghu501@163.com+86 10 8302 4081

Outcome results

None listed

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