Non-suicidal Self-injuryNCT07486804
Effects of taVNS Combined With tACS on Adolescents With Non-Suicidal Self-Injury
A study testing 25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulation in people with Non-suicidal Self-injury, run by Anhui Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Non-suicidal Self-injury
- What is being tested?
- 25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
School of Mental Health and Psychological Sciences
Hefei, Anhui
Lei Zhang, +86 18155313002, anyipsychology@163.com
About this study
Official title: Effects of Combined taVNS and tACS on Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Non-suicidal Self-injury
- Being tested
- 25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulation, sham 25Hz、300us transcutaneous auricular vagus nerve stimulation and 10hz transcranial alternating current stimulation, active 25Hz、300us transcutaneous auricular vagus nerve stimulation and sham10hz transcranial alternating current stimulation
- Keywords
- non-suicidal self-injury, transcranial alternating current stimulation, taVNS, tACS, state-dependant
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulationDevice
The active taVNS stimulation was applied to the cymba conchae, an area exclusively innervated by the auricular branch of the vagus nerve. Active taVNS stimulation protocol was set as follows: pulse width of 300 μs, frequency of 25 Hz, and current intensity adjusted based on each participant's individual threshold, set at 80% of the sensory threshold. The stimulation duration was 15 minutes.
Active 10hz transcranial alternating current stimulation: 10 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).
sham 25Hz、300us transcutaneous auricular vagus nerve stimulation and 10hz transcranial alternating current stimulationDevice
The sham taVNS stimulation was placed on the earlobe. The two procedures were indistinguishable in terms of appearance, ensuring effective blinding. The stimulation duration was 15 minutes.
Active 10HZ transcranial alternating current stimulation: 10 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).
active 25Hz、300us transcutaneous auricular vagus nerve stimulation and sham10hz transcranial alternating current stimulationDevice
The active taVNS stimulation was applied to the cymba conchae, an area exclusively innervated by the auricular branch of the vagus nerve. active taVNS stimulation protocol was set as follows: pulse width of 300 μs, frequency of 25 Hz, and current intensity adjusted based on each participant's individual threshold, set at 80% of the sensory threshold. The stimulation duration was 15 minutes.
Sham 10HZ 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).
| Study group | Role | What they receive |
|---|---|---|
| Combined Stimulation Group | Experimental | deliver 15 minutes taVNS and 20 minutes of 10hz tACS intervention Receives: Device: 25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulation |
| tACS-Only Group | Active comparator | deliver sham 15 minutes taVNS and 20 minutes of 10hz tACS intervention Receives: Device: sham 25Hz、300us transcutaneous auricular vagus nerve stimulation and 10hz transcranial alternating current stimulation |
| taVNS-Only Group | Placebo comparator | deliver 15 minutes taVNS and 20 minutes of sham 10hz tACS sham intervention ，but 10 Hz active sham control the current will be ramped up to 2 mA and then ramped down to 0 mA within the first 30 seconds. Receives: Device: active 25Hz、300us transcutaneous auricular vagus nerve stimulation and sham10hz transcranial alternating current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Higher frequencies indicate more severe NSSI behavior.
Measured: Assessments were conducted at baseline (pre-treatment), as well as on day 1, at week 1, and at month 1 post-treatment.
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. Total score: 32. Higher scores indicate greater impulsivity.
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
Eye movement index-fixation counts
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.
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
Stop Signal Task（SST）
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.
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
Delay Discounting Task (DDT)
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.、
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
Secondary outcomes (7)
Hamilton Depression Scale (HAMD-17) score
The Hamilton Depression Rating Scale (HAMD) is a clinician-administered questionnaire widely used to assess the severity of depressive symptoms. The 17-item version (HAMD-17) is the most commonly used, with total scores ranging from 0 to 52. Higher scores indicate greater severity of depression
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
Hamilton Anxiety Scale (HAMA-14) score
The Hamilton Anxiety Rating Scale (HAMA-14) is a clinician-administered scale assessing the severity of anxiety symptoms. It comprises 14 items, with total scores ranging from 0 to 56. Higher scores indicate greater anxiety severity.
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
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.
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
The score of Ruminative Responses Scale (RRS)
The Ruminative Responses Scale (RRS) is a self-report measure assessing rumination, defined as repetitive and passive thinking about negative emotions and their causes. The 22-item version yields total scores from 22 to 88, with higher scores indicating more frequent rumination.
Measured: 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)
The Difficulties in Emotion Regulation Scale-Short Form (DERS-16) is a 16-item self-report measure assessing emotion dysregulation across multiple dimensions. It assesses five dimensions: non-acceptance of emotional responses, difficulties engaging in goal-directed behavior, impulse control difficulties, limited access to emotion regulation strategies, and lack of emotional clarity.Total scores range from 16 to 80, with higher scores indicating greater difficulties in emotion.
Measured: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
The Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report scale assessing depression severity based on DSM-5 criteria. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Scores ≥10 suggest moderate depression.
Measured: 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)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report screening tool for anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity. Scores ≥10 indicate moderate anxiety.
Measured: Assessments were conducted at baseline (pre-treatment), as well as on day 1, at week 1, and at month 1 post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start16 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-suicidal Self-injuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyan Zhu, Anhui Medical University
- Investigators
- Hongyan Zhu, Principal investigator, School of Mental Health and Psychological Sciences, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486804
- Sponsor's protocol ID
- 81251050
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined taVNS and tACS on Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07486804
- Acronym / sponsor ID
- 81251050
- Conditions
- Non-suicidal Self-injury
- Keywords
- non-suicidal self-injury, transcranial alternating current stimulation, taVNS, tACS, state-dependant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined Stimulation Group | Experimental | Device: 25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulationdeliver 15 minutes taVNS and 20 minutes of 10hz tACS intervention |
| tACS-Only Group | Active comparator | Device: sham 25Hz、300us transcutaneous auricular vagus nerve stimulation and 10hz transcranial alternating current stimulationdeliver sham 15 minutes taVNS and 20 minutes of 10hz tACS intervention |
| taVNS-Only Group | Placebo comparator | Device: active 25Hz、300us transcutaneous auricular vagus nerve stimulation and sham10hz transcranial alternating current stimulationdeliver 15 minutes taVNS and 20 minutes of sham 10hz tACS sham intervention ，but 10 Hz active sham control the current will be ramped up to 2 mA and then ramped down to 0 mA within the first 30 seconds. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulationThe active taVNS stimulation was applied to the cymba conchae, an area exclusively innervated by the auricular branch of the vagus nerve. Active taVNS stimulation protocol was set as follows: pulse width of 300 μs, frequency of 25 Hz, and current intensity adjusted based on each participant's individual threshold, set at 80% of the sensory threshold. The stimulation duration was 15 minutes. Active 10hz transcranial alternating current stimulation: 10 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). | Device | Combined Stimulation Group |
| sham 25Hz、300us transcutaneous auricular vagus nerve stimulation and 10hz transcranial alternating current stimulationThe sham taVNS stimulation was placed on the earlobe. The two procedures were indistinguishable in terms of appearance, ensuring effective blinding. The stimulation duration was 15 minutes. Active 10HZ transcranial alternating current stimulation: 10 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). | Device | tACS-Only Group |
| active 25Hz、300us transcutaneous auricular vagus nerve stimulation and sham10hz transcranial alternating current stimulationThe active taVNS stimulation was applied to the cymba conchae, an area exclusively innervated by the auricular branch of the vagus nerve. active taVNS stimulation protocol was set as follows: pulse width of 300 μs, frequency of 25 Hz, and current intensity adjusted based on each participant's individual threshold, set at 80% of the sensory threshold. The stimulation duration was 15 minutes. Sham 10HZ 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). | Device | taVNS-Only Group |
Primary outcome
Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury
Time frame: 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)
Time frame: 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
Time frame: 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）
Time frame: 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)
Time frame: 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.、
7 secondary outcomes
Hamilton Depression Scale (HAMD-17) score
Time frame: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
Hamilton Anxiety Scale (HAMA-14) score
Time frame: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
the score of PANSI
Time frame: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
The score of Ruminative Responses Scale (RRS)
Time frame: 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)
Time frame: Assessments were conducted at baseline (pre-treatment) and on day 1 post-treatment.
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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)
Time frame: Assessments were conducted at baseline (pre-treatment), as well as on day 1, at week 1, and at month 1 post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongyan Zhu principal investigator
School of Mental Health and Psychological Sciences, Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25Hz、300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulation in people with Non-suicidal Self-injury, run by Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongyan Zhu (＋ 86 18155313002, 2445011125@stu.ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury (time frame: Assessments were conducted at baseline (pre-treatment), as well as on day 1, at week 1, and at month 1 post-treatment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.