Effects of Combined taVNS and tACS on Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury
研究概览
简要总结
NSSI behavior is highly prevalent among adolescents, and its mechanisms are closely associated with attentional bias toward self-injury-related information and impulsivity, both of which may be related to reduced dlPFC activation levels. Introducing taVNS as a priming stimulus to pre-regulate brain state and optimize subsequent tACS treatment response provides a novel approach to addressing inconsistent intervention effects. Simultaneously, this facilitates a shift in the brain from passive stimulus reception to active state regulation, offering important theoretical foundations for developing more precise and efficient cross-modal neuromodulation therapies.This study aims to systematically validate the efficacy of a combined protocol using taVNS as a priming modality followed by tACS over the left dlPFC through a randomized controlled trial (RCT). The investigators hypothesize that:
① Compared to tACS intervention alone, this combined approach will not only demonstrate non-inferiority in overall therapeutic efficacy but, more importantly, significantly reduce inter-individual variability in treatment response to tACS. This would mitigate the issue of high clinical response heterogeneity and enhance the stability and predictability of treatment outcomes.
② Early behavioral biomarkers of intervention response are anticipated: Immediate improvements in attentional bias following a single combined intervention session will significantly predict reductions in the frequency and intensity of Non-Suicidal Self-Injury (NSSI) after a full course (14 sessions) of treatment. This suggests that early positive changes in cognitive function could serve as valid indicators predicting long-term clinical efficacy, offering a critical time window for implementing individualized treatment adjustments.
③ The study will elucidate the effects of the taVNS-primed combined tACS treatment on neuroimaging mechanisms in adolescents with NSSI.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the proposed diagnostic criteria for non-suicidal self-injury (NSSI) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with ≥5 documented self-injury episodes and at least one incident within the past month as assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ)
- •Aged 12-18 years
- •Right-handed
- •Possess formal education experience sufficient to comprehend experimental protocols
- •Normal or corrected-to-normal binocular visual acuity
- •Voluntarily participate with legal guardians providing written informed consent
排除标准
- •Montreal Cognitive Assessment (MoCA) score < 26
- •History of suicide attempts
- •History of epilepsy, brain surgery, tumors, or clinically significant head trauma
- •History of substance abuse or severe physical diseases
- •Received physical or psychological interventions within the past three months
结局指标
主要结局
Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury
时间窗: Assessments were conducted at baseline (pre-treatment), as well as on day 1, at week 1, and at month 1 post-treatment.
The ANSAQ is a brief, self-report tool specifically designed for adolescents aged 12-18 to quantify non-suicidal self-injury (NSSI) over the past year. It is used both to screen for clinically relevant self-harm and to track changes in self-injury frequency after an intervention. Higher frequencies indicate more severe NSSI behavior.
Brief Barratt Impulsiveness Scale (BBIS)
时间窗: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
The BBIS is an 8-item, self-report subset of the well-known Barratt Impulsiveness Scale. Each item (e.g., "I act on the spur of the moment") is answered on a 4-point scale: 1 = rarely/never, 2 = occasionally, 3 = often, 4 = almost always/always. Total scores range 8-32; higher scores indicate greater impulsivity. Total score: 32. Higher scores indicate greater impulsivity.
Eye movement index-fixation counts
时间窗: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
A free-viewing paradigm consisting of 60 images was employed, with eye movements recorded using an SMI-RED eye-tracking system. Each trial comprised a four-image array: three neutral stimuli and one NSSI-related stimulus, presented for 4000 ms. A dot-probe paradigm consisting of 204 trials was employed, with eye movements recorded using an SMI-RED eye-tracking system. Each trial comprised a pair of images: one neutral stimulus and one NSSI-related stimulus, presented for either 200 ms or 500 ms.The region of interest (ROI) was defined as the area containing the NSSI-related cue. 'Dwell time' was operationalized as the total duration (in milliseconds) that the eyes remained fixated within the ROI during image presentation. Values were averaged across all NSSI-related cue images at baseline (Day 0) and post-intervention (Day 8). A clinically relevant improvement in inhibitory control was defined as a ≥20% reduction in total dwell time on NSSI-related cues relative to baseline.
Stop Signal Task（SST）
时间窗: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
The experiment consisted of 192 trials (64 × 3), preceded by a 20-trial practice phase. Each trial began with a 1.5-second fixation cross, followed by a left- or right-pointing arrow (maximum duration: 2 seconds), to which participants responded as quickly and accurately as possible. In approximately 25% of trials, an auditory stop signal was presented after a variable delay, requiring participants to inhibit their response. The stop-signal delay (SSD) was dynamically adjusted using a staircase procedure (initial delay: 250 ms; ±50 ms based on performance) to index inhibitory control. The inter-trial interval was fixed at 30 seconds.
Delay Discounting Task (DDT)
时间窗: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
The study employed a Delay Discounting Task (DDT) to assess individuals' preference for immediate versus delayed rewards. The task included 80 trials, generated by fully crossing four delayed reward amounts (¥25, ¥50, ¥100, ¥500), five delay durations (7, 14, 30, 90, and 180 days), and four discount rates (70%, 85%, 90%, and 95%). Each trial began with a 1.5-second fixation cross, followed by a simultaneous presentation of two options: a smaller immediate reward and a larger delayed reward, with their positions randomized across trials. Participants selected their preferred option using the left or right arrow keys, and no feedback was provided.、
次要结局
- the score of PANSI(Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.)
- Hamilton Depression Scale (HAMD-17) score(Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.)
- Hamilton Anxiety Scale (HAMA-14) score(Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.)
- The score of Ruminative Responses Scale (RRS)(Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.)
- The score of Difficulties in Emotion Regulation Scale-Short Form (DERS-16)(Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.)
- The Patient Health Questionnaire-9 (PHQ-9)(Assessments were conducted at baseline (pre-treatment), as well as on day 1, at week 1, and at month 1 post-treatment.)
- The Generalized Anxiety Disorder-7 (GAD-7)(Assessments were conducted at baseline (pre-treatment), as well as on day 1, at week 1, and at month 1 post-treatment.)
研究者
Hongyan Zhu
Graduate Student Researcher
Anhui Medical University