Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
ConditionSelf-Injurious Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorShanghai Mental Health Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of NSSI based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria section 3 diagnostic criteria.
Five or more NSSI episodes in the past year and at least one NSSI episode in the past month.
Age between 12 and 21 years.
Informed consent from parents or legal guardians.
Disqualifiers
Current or history of organic brain disorders or neurological disorders.
Elevated or imminent suicidal risk, as assessed by clinicians during routine screening.
Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, TMS, transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments.
Presence of cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain.
Trial design
Design model
Parallel
Treatments tested in this trial
Active-tACS
DeviceParticipants 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
DeviceThe 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: the active-tACS groupExperimental treatment 1 intervention
Group B: the sham-tACS groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in total NSSI incidents during the 4-week follow-up period post-intervention
It will be determined by the Suicide and Self-Injury Behavior Interview-Revised (SITBI-R). The primary outcome is the proportion of participants achieving a ≥50% decrease in NSSI frequency within the past month at Day 42, as measured by the SITBI-R. A threshold of 50% reduction was selected based on its clinical relevance as an indicator of intervention efficacy.
Time frame
6 weeks2
Change in mean NSSI severity levels during the 4-week follow-up period post-intervention
It will be determined by the Suicide and Self-Injury Behavior Interview-Revised (SITBI-R). The SITBI-R assesses NSSI severity using a 5-point scale (minimum = 1, maximum = 5), where higher scores indicate more severe outcomes: Level 1 (mild NSSI without skin damage) to Level 5 (severe NSSI requiring medical intervention). Comparative analysis of severity-level changes between the active-tACS and sham-tACS groups will be conducted at the 4-week follow-up post-intervention.
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov