Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT06919432
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Sponsor:
Shanghai Mental Health Center
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Recognizing the clinical shortcomings of traditional methods for adolescent NSSI, study objective is to establish evidence supporting the efficacy of a triple-daily 15mA-tACS stimulation regimen targeting the forehead and both mastoids. This intervention will be administered five days a week over a four-week treatment period, with the aim of eliciting substantial clinical improvements in adolescent NSSI compared to a sham intervention. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days. Following the completion of treatment, participants will undergo follow-up observations every 7 days for 4 weeks. EEG and ECG recordings will be obtained at baseline, on day 1 after the first session, at the end of the 2-week intervention period (after 40 sessions), and at the 6-week follow-up. Throughout the sessions, all evaluations will be conducted under standardized conditions.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: