Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical trial aims to determine whether beta-band transcranial alternating current stimulation (tACS) can improve impulse inhibition in adolescents with non-suicidal self-injury (NSSI) and to evaluate its safety. The primary questions it seeks to answer are:
Researchers will compare beta-band tACS with sham stimulation (a procedure that mimics the real stimulation without delivering effective current) to verify its efficacy.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | Active stimulation: deliver 20 minutes of beta-band tACS intervention. |
|
| Control group | Sham Comparator | Sham stimulation will be administered with identical treatment parameters, duration, and number of sessions as the active intervention. For the control group, the current will be ramped up to 2 mA and then ramped down to 0 mA within the first 30 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-frequency transcranial alternating current stimulation | Device | Active beta-frequency transcranial alternating current stimulation: 20 Hz tACS delivered through a 4×1-ring high-definition electrode montage centered on left DLPFC (F3), 2 mA peak-to-peak, 100 % intensity, gradually ramped up over 30 s, maintained for 20 min, then ramped down over 30 s; two sessions per day with at least 4 h between sessions, repeated for 7 consecutive days (14 total sessions). |
| Measure | Description | Time Frame |
|---|---|---|
| Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury | 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. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| UPPS-P Impulsive Behavior Scale (UPPS-P) | The UPPS-P is a 59-item self-report questionnaire that measures five distinct facets of impulsivity: Negative Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation Seeking, and Positive Urgency. Each item is rated on a 4-point Likert scale from 1 (agree strongly) to 4 (disagree strongly); items are reverse-scored so that higher scores indicate greater impulsivity. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| Brief Barratt Impulsiveness Scale (BBIS) | 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. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| Eye movement index-fixation time | Recorded with an SMI-RED eye-tracker while participants freely view 60 pictures in the NSSI-cue reactivity paradigm. Each picture (tool cue, use cue, association cue, or neutral cue) is presented for 4 000 ms. The Region of Interest (ROI) is the entire picture area. "Fixation time" is the total duration (ms) that gaze remains within this ROI during picture presentation. Values are averaged across all cue types (or separately for NSSI-relevant vs. neutral cues) at baseline (Day 0) and post-intervention (Day 8). A ≥ 20 % reduction in total fixation time on NSSI-relevant cues relative to baseline is defined as a clinically relevant improvement in inhibitory control. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAMD-17) score | The HAMD-17 is a clinician-rated scale of depressive symptoms. Seventeen items (mood, sleep, guilt, etc.) are scored 0-2 or 0-4; total ranges 0-52. Higher scores indicate more severe depression. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meiling Wang, bachelor | Contact | +86 136 4707 0027 | 1605280093@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, doctor | School of Mental Health and Psychological Sciences, Anhui Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Mental Health and Psychological Sciences, Anhui Medical University | Recruiting | Hefei | Anhui | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| sham beta-frequency transcranial alternating current stimulation | Device | Sham transcranial alternating current stimulation: identical 4×1-ring high-definition electrode montage centered on left DLPFC (F3), 2 mA peak-to-peak current ramped up over 30 s and immediately ramped down to 0 mA, followed by 19.5 min of no stimulation to match the 20-min session duration of active tACS; delivered twice daily (≥4 h apart) for 7 consecutive days (14 total sessions). |
|
| Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| Eye movement index-fixation counts | During the NSSI cue-reactivity paradigm, an SMI-RED eye-tracker records gaze while 60 pictures (tool, use, association, or neutral cues) are each displayed for 4 000 ms. The entire picture is defined as the Region of Interest (ROI). "Fixation counts" is the total number of discrete fixations that fall within this ROI. The score is averaged across all pictures (or separately for NSSI-relevant vs. neutral cues) at baseline (Day 0) and after the 7-day intervention (Day 8). A ≥ 20 % reduction in fixation counts on NSSI-relevant cues from baseline indicates improved impulse inhibition. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| Balloon Analog Risk Task-Total number of Balloon explosions | In the computer-based Balloon Analog Risk Task (BART), participants are shown 30 virtual balloons one at a time. They press "F" to inflate (pump) each balloon; every pump increases potential earnings by ¥0.5 but also raises the risk of explosion. Explosion points are random (1-128 pumps, mean 64). Participants can press "J" at any time to stop inflating and bank the current reward. "Total number of balloon explosions" is the count of balloons that burst across all 30 trials. Higher numbers reflect greater risk-taking and poorer impulse control. The score is obtained at baseline (Day 0) and after the 7-day intervention (Day 8); a ≥ 20 % reduction in explosions from baseline is considered a clinically relevant improvement in inhibitory control. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| Hamilton Anxiety Scale (HAMA-14) score |
The HAMA-14 is a clinician-rated scale that assesses the severity of anxiety symptoms. It contains 14 items covering psychic and somatic anxiety; each item is scored 0 (not present) to 4 (very severe), giving a total range of 0-56, with higher scores indicating greater anxiety. |
| Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| the score of Moca | A 30-point clinician-administered screen covering eight cognitive domains: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Each correct response earns 1 point; scores 0-30 with ≥ 26 considered normal. Used in this study to exclude participants with cognitive impairment (< 26). | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| the score of TAS-20 | Self-report measure of alexithymia with 20 items rated 1-5, yielding three subscales: Difficulty Identifying Feelings, Difficulty Describing Feelings, and Externally Oriented Thinking. Total score 20-100; ≥ 61 indicates clinically significant alexithymia. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| the score of ERQ | The ERQ is a 10-item self-report scale that measures habitual use of two emotion-regulation strategies: Cognitive Reappraisal (6 items) and Expressive Suppression (4 items). Each item is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Sub-scale scores are generated by summing respective items: Reappraisal range 6-42, Suppression range 4-28. Higher scores indicate more frequent use of the strategy. The scale shows good internal consistency (α ≥ .79) and 3-month test-retest reliability (r ≈ .69) in adolescents . | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| the score of PANSI | 14-item self-report that gauges both protective (positive) and risk-related (negative) aspects of suicide ideation in adolescents. Items are rated 1-5; higher totals on the 6-item Positive Ideation sub-scale (range 6-30) indicate greater resilience, while higher totals on the 8-item Negative Ideation sub-scale (range 8-40) signal increased suicide risk. | Once at baseline (pre-treatment) and once at the end of treatment on Day 8. |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided