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
Qualifiers
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
Treatments tested in this trial
- Active-tACS
- Sham-tACS
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov