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Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Sponsor: Shanghai Mental Health Center
Summary
In order to assess the clinical efficacy of triple-daily 15mA-tACS stimulation by comparing the effects of active and sham tACS interventions on driving improvements in adolescent Nonsuicidal Self-Injury(NSSI), participants will be randomly assigned to either the active or sham tACS group. This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. The key hypothesis is that triple-daily 15mA-tACS stimulation will enhance clinical recovery compared to sham stimulation.
Official title: Efficacy of Triple-daily 15mA Transcranial Alternating Current Stimulation on Adolescent Non-suicidal Self-injury (NSSI): a Double-blind, Randomized, Sham-controlled Trial
Key Details
Gender
All
Age Range
12 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-05-01
Completion Date
2027-09-30
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
Active-tACS
Participants were comfortably positioned on a lounge chair and received alternating current stimulation using an FDA-approved tACS device (Nexalin Technology, Inc., Houston, TX, USA). Electrodes were evenly placed across the forehead and mastoid regions. Trained nurses administered the tACS according to standardized protocols.
Sham-tACS
The sham tACS device will resemble the active stimulation device in appearance, weight, size, color, and odor, ensuring indistinguishability for the patients. Throughout the entire intervention period, each participant will be allocated to the same tACS device, regardless of whether it delivers active or sham stimulation.
Locations (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China