Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active-tACS, Sham-tACS.
- Who it may be relevant to
- Registry conditions: Self-Injurious Behavior. Basic parameters: 12 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Change in total NSSI incidents during the 4-week follow-up period post-intervention [Time frame: 6 weeks]
- Change in mean NSSI severity levels during the 4-week follow-up period post-intervention [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- 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.
- Informed consent from participants aged 15 years and above.
Exclusion criteria
- 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.
- Previous or current use of psychotropic medication.
- Pregnancy or lactation.
- Participation in another concurrent clinical trial.
- Refusal to provide informed consent to participate in the trial.
- Other circumstances deemed unsuitable for participation by researchers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Mental Health Center — Shanghai
Identifiers
NCT: NCT06919432 · 2024y1023