Skip to content

Clinical Efficacy Study on the Treatment of Depressive Disorders with Transcranial Alternating Current Stimulation (Nexalin ADI)

Clinical Efficacy Study on the Treatment of Depressive Disorders with Transcranial Alternating Current Stimulation (Nexalin ADI)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093901
Enrollment
Unknown
Registered
2024-12-13
Start date
2024-12-20
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Depressive disorder

Interventions

Active tACS stimulation group:Participants are randomly assigned to receive 30 active stimulations, each lasting 40 minutes, with electrodes placed on The frontal lobe and bilateral mastoids, at a fre
Sham tACS stimulation group:Participants are randomly assigned to receive 30 sham stimulations, each lasting 40 minutes, with electrodes placed on the frontal lobe and bilateral mastoids, at a frequen

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: a. Major depressive episode diagnosed according to DSM-5, bipolar I and II disorders; b. Aged 14-65 years; c. Gender and ethnicity are not limited; d. Hamilton's 17 depression scores were HAMD >=17, and the first item was >=2 ; e. For patients who have not received treatment for depression disorder other than medication within two weeks of the inclusion time, the medication and its dose remain unchanged for two weeks before and during treatment for those who have taken medication; f. Education level of junior high school or above; g. Can accept numbness, slight tingling and other discomfort that may occur during treatment; h. Patients sign informed consent;

Exclusion criteria

Exclusion criteria: a. High risk of suicide (the third suicide score of HAMD-17 is greater than 3); b. Pregnant women; c. Clinically diagnosed neurologic disorders such as epilepsy, stroke, Alzheimer's disease, Parkinson's disease; d. Head trauma or skin disease; e. Any implant or implant device in the head that interacts with tDCS or tACS currents; f. Changed treatment regiments within two weeks prior to inclusion; g. Received any neuroregulatory therapy (e.g. (M)ECT, (r)TMS, tES) within the past three months; h. Psychotic disorders, obsessive-compulsive disorders, phobias, panic disorders or stress-related disorders; i. Abusers of any type of substance, such as alcohol or drugs, at the time of inclusion; j. People who have recently taken benzodiazepines or antiepileptic mood stabilizers (based on the 5-half-life of the drug);

Design outcomes

Primary

MeasureTime frame
The reduction ratio of HAMD-17 score at the end of the 6th week of treatment;

Countries

China

Contacts

Public ContactWu Hong

Shanghai Mental Health Center

drhongwu@126.com+86 136 1197 8319

Outcome results

None listed

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