Efficacy of Triple-daily 15mA Transcranial Alternating Current Stimulation on Adolescent Non-suicidal Self-injury (NSSI): a Double-blind, Randomized, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in total NSSI incidents during the 4-week follow-up period post-intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both clinical staff and participants were blinded to the assignment.
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
the active-tACS group
This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days.
干预措施: Active-tACS (Device)
the sham-tACS group
Participants in the sham-tACS group will undergo the same protocol, utilizing a sham tACS incapable of delivering active stimulation. They will be kept unaware of their assigned treatment.
干预措施: Sham-tACS (Device)
结局指标
主要结局
Change in total NSSI incidents during the 4-week follow-up period post-intervention
时间窗: 6 weeks
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.
Change in mean NSSI severity levels during the 4-week follow-up period post-intervention
时间窗: 6 weeks
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.
次要结局
未报告次要终点
研究者
Tianhong ZHANG
Associate Professor
Shanghai Mental Health Center