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Non-suicidal Self-injury (NSSI)NCT06919432

Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

A study testing Active-tACS (Nexalin Technology, Inc., Houston, TX, USA) in people with Non-suicidal Self-injury (NSSI), run by Shanghai Mental Health Center at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the clinical effectiveness of triple-daily 15 mA tACS stimulation in adolescents with Nonsuicidal Self-Injury (NSSI) by comparing the outcomes of active versus sham tACS interventions. Participants will be randomly assigned to either the active or sham tACS group. Read more about this study

Who is it for?
Ages 12 to 21 years
Conditions the study is for
Non-suicidal Self-injury (NSSI)
What is being tested?
Active-tACS (Nexalin Technology, Inc., Houston, TX, USA)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteChina
Study dates
1 May 2025to 30 Sep 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 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis of Non-Suicidal Self-Injury (NSSI) according to the DSM-5 Section III diagnostic criteria, including:
  • Criterion A: At least five or more NSSI episodes in the past year.
  • Criterion B: NSSI is expected to relieve interpersonal difficulties, negative thoughts or emotions, or induce a positive emotional state.
  • Criterion C: Prior to NSSI, the individual experiences one or more of the following: interpersonal problems, negative thoughts or emotions, distress that is difficult to control, or frequent preoccupation with NSSI.
  • Criterion D: NSSI is socially unacceptable or limited to minor self-injury.
  • Criterion E: NSSI causes clinically significant distress or impairment in social, academic, or other important areas of functioning.
Show all 10Show fewer
  • Criterion F: NSSI is not better explained by psychotic disorder, delirium, substance use/withdrawal, or another medical or mental disorder.
  • At least one NSSI episode in the past month.
  • Age 12 to 21 years.
  • Informed consent obtained from participants; for those under 18, consent must also be obtained from parents or legal guardians.

Who cannot join

  • Current or past organic brain disorders or neurological disorders.
  • High or imminent risk of suicide, as assessed by clinicians during routine screening.
  • Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments.
  • Presence of cochlear implants, cardiac pacemakers, implanted medical devices, or metal in the brain.
  • Previous or current use of psychoactive or psychotropic substances.
  • Pregnancy or lactation.
Show all 9Show fewer
  • Participation in another ongoing clinical trial.
  • Refusal to provide informed consent to participate.
  • Other circumstances deemed unsuitable for participation by the investigators.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

TianHong Zhang, Doctor contact

13127577024

zhang_tianhong@126.com

China1 site, 1 recruiting
  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

    TianHong Zhang, Doctor, 13127577024, zhang_tianhong@126.com

    Recruiting

Other trials in China

About this study

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

This study aims to evaluate the clinical effectiveness of triple-daily 15 mA tACS stimulation in adolescents with Nonsuicidal Self-Injury (NSSI) by comparing the outcomes of active versus sham tACS interventions. Participants will be randomly assigned to either the active or sham tACS group. The trial includes a seven-day intervention phase, during which participants receive treatment three times daily, followed by a four-week observation period.

The primary hypothesis is that triple-daily 15 mA tACS will significantly reduce both the severity and frequency of self-injurious behaviors compared with sham stimulation. The study's overall goal is to provide evidence for an effective intervention to help adolescents manage and reduce NSSI behaviors.

Read the detailed description

Recognizing the limitations of traditional approaches for managing adolescent NSSI, the present study aims to establish evidence for the efficacy of a triple-daily 15 mA tACS stimulation protocol targeting the forehead and bilateral mastoids. The intervention will be delivered seven consecutive days, with the goal of producing clinically meaningful improvements in NSSI compared with sham stimulation.

Clinical assessments will be conducted at baseline, at the end of treatment week, and weekly throughout the 4-week follow-up period to monitor changes in symptom severity continuously from baseline through follow-up.

EEG, ECG, and SEP will be recorded at three time points: baseline (pre-intervention), after the first tACS session (Day 1), and at the end of 7 treatment days. On Day 1, SEP recordings will be used to assess primary somatosensory cortical responses.

At baseline, and at the end of the intervention, EEG assessments will additionally incorporate the capsaicin-induced sensitization paradigm (to evaluate pain sensitivity) and the Cyberball paradigm (to examine neural responses to social exclusion). Eye-tracking assessments will also be conducted at these three time points to evaluate oculomotor function and emotion recognition.

All physiological and behavioral measurements will be conducted under standardized, controlled laboratory conditions.

Being tested
Sham-tACS (Nexalin Technology, Inc., Houston, TX, USA), Active-tACS (Nexalin Technology, Inc., Houston, TX, USA)
Keywords
Non-suicidal self-injury (NSSI), Adolescent NSSI, Non-invasive brain stimulation, Transcranial alternating current stimulation (tACS), Neuromodulation, Self-harm intervention
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.

  • Sham-tACS (Nexalin Technology, Inc., Houston, TX, USA)Device

    Participants assigned to the sham-tACS group use a device identical in appearance, weight, size, color, and odor to the active device. The device delivers no effective stimulation but mimics the procedure and duration of the active-tACS sessions (triple-daily sessions). Sessions are administered by trained personnel following the same schedule as the active-tACS group. Participants remain blinded to their group assignment throughout the study.

  • Active-tACS (Nexalin Technology, Inc., Houston, TX, USA)Device

    Participants are comfortably seated or reclined in a lounge chair and instructed to remain relaxed with minimal interaction during the session. Alternating current stimulation is delivered at 77.5 Hz (±10%) with a current intensity gradually increasing from 1 mA to 15 mA in 2 mA increments. Each increment lasts 300 seconds, with variable intervals between intensity steps (1-3 mA: 5 s; 3-5 mA: 5 s; 5-7 mA: 5 s; 7-9 mA: 5 s; 9-11 mA: 6 s; 11-13 mA: 7 s; 13-15 mA: 10 s). Electrodes are placed on the forehead (4.45 × 9.53 cm, Fpz, Fp1, Fp2) and bilaterally over the mastoids (3.18 × 3.81 cm), following the international 10/20 system. The total stimulation duration at 15 mA is 40 minutes. Stimulation is imperceptible, and the device operates silently. All sessions are administered by trained study personnel following standardized protocols.

Study groups in NCT06919432
Study groupRoleWhat they receive
Active-tACS GroupExperimentalParticipants in the active tACS group will undergo a 7-day intervention phase, receiving three sessions per day with approximately 2-hour intervals between sessions, followed by a 4-week observation period.
Receives: Device: Active-tACS (Nexalin Technology, Inc., Houston, TX, USA)
Sham-tACS GroupSham comparatorParticipants in the sham-tACS group follow the same 7-day intervention schedule, receiving three sessions per day with approximately 2-hour intervals between sessions, followed by a 4-week observation period.
Receives: Device: Sham-tACS (Nexalin Technology, Inc., Houston, TX, USA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in NSSI frequency from baseline to 4-week post-intervention follow-up

    NSSI frequency will be assessed using the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R). The primary outcome is the change in the total number of NSSI episodes between the 4-week period preceding baseline and the 4-week post-intervention follow-up period. NSSI frequency ranges from 0 to no predefined maximum, with higher counts indicating more frequent NSSI behaviors. Change scores will be calculated as follow-up minus baseline, with negative values indicating reduced NSSI frequency and better clinical outcomes.

    Measured: Baseline (4-week retrospective period) and 4 weeks after intervention completion (assessed at post-intervention weeks 1, 2, and 4)

Secondary outcomes (29)
  1. NSSI injury severity during the intervention and post-intervention follow-up periods

    NSSI injury severity will be assessed using items 5-10 of SITBI-R. Injury severity is rated on a five-point scale ranging from 1 (minimal injury) to 5 (severe injury requiring medical intervention), with higher scores indicating greater injury severity and worse clinical outcomes. Injury severity will be evaluated separately for the 7-day intervention period and the 4-week post-intervention follow-up period. The mean severity score across applicable NSSI events will be calculated separately for each period.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  2. NSSI frequency during the 7-day intervention period

    NSSI frequency will be assessed using SITBI-R. The outcome is defined as the total number of NSSI episodes occurring during the 7-day intervention period. The number of episodes ranges from 0 to no predefined maximum, with higher counts indicating more frequent NSSI behaviors and worse clinical outcomes.

    Measured: Baseline and end of the 7-day intervention

  3. Self-reported self-harm behaviors

    Self-reported self-harm behaviors will be assessed using the 7-item version of the Deliberate Self-Harm Inventory (DSHI). Each item is rated on a 4-point scale: 0 (never), 1 (1-2 times), 2 (3-5 times), and 3 (6 or more times). Total scores range from 0 to 21, with higher scores indicating greater self-harm behavioral frequency burden and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  4. Self-injury dependence

    Self-injury dependence will be assessed using the Ottawa Self-Injury Inventory (OSI), a self-report questionnaire evaluating dependence-related characteristics of NSSI, including urges to self-injure, difficulty controlling or stopping self-injury, and interference with daily functioning. The dependence-related section includes seven items rated on a five-point scale from 0 (never) to 4 (always). Total scores range from 0 to 28, with higher scores indicating greater self-injury dependence and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 4 weeks post-intervention

  5. NSSI urge intensity

    Momentary NSSI urge intensity will be assessed using a single item from the NSSI Urge and Resistance Efficacy Scale. Participants rate the intensity of their current urge to engage in NSSI on a 7-point scale ranging from 1 (no urge at all) to 7 (extremely strong urge or difficult to suppress). Higher scores indicate stronger NSSI urges and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  6. Perceived ability to resist NSSI urges

    Perceived ability to resist NSSI urges will be assessed using a single item from the NSSI Urge and Resistance Efficacy Scale. Participants rate their perceived ability to resist NSSI urges on a 7-point scale ranging from 1 (no ability to resist) to 7 (completely able to resist). Higher scores indicate greater perceived ability to resist NSSI urges and better clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  7. Self-efficacy in resisting NSSI urges

    Self-efficacy in resisting NSSI urges will be assessed using the NSSI Urge and Resistance Efficacy Scale. Participants rate their confidence in resisting NSSI urges on a 7-point scale ranging from 1 (no confidence at all) to 7 (complete confidence). Higher scores indicate greater self-efficacy in resisting NSSI urges and better clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  8. Suicidal ideation severity

    Suicidal ideation severity will be assessed using the Beck Scale for Suicide Ideation (BSSI), a 19-item measure evaluating suicidal thoughts, wishes, and attitudes during the preceding week. Each item is scored from 0 to 2, yielding a total score ranging from 0 to 38. Higher scores indicate more severe suicidal ideation and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  9. Depressive symptom severity

    Depressive symptom severity will be assessed using the 24-item Hamilton Depression Rating Scale (HAMD-24), a clinician-rated instrument evaluating the severity of depressive symptoms. Total scores range from 0 to 76, with higher scores indicating more severe depressive symptoms and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  10. Self-reported depressive symptom severity

    Self-reported depressive symptom severity will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  11. Anxiety symptom severity

    Anxiety symptom severity will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-rated instrument evaluating psychological and somatic symptoms of anxiety. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate more severe anxiety symptoms and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  12. Self-reported anxiety symptom severity

    Self-reported anxiety symptom severity will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). Each item is scored from 0 to 3, yielding a total score ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 1, 2, and 4 weeks post-intervention

  13. Emotion regulation difficulties

    Emotion regulation difficulties will be assessed using the 16-item Difficulties in Emotion Regulation Scale (DERS-16), a self-report questionnaire evaluating difficulties in emotional awareness and clarity, acceptance of emotional responses, impulse control, and goal-directed behavior during emotional distress. Each item is rated on a 5-point scale from 1 (almost never) to 5 (almost always), yielding a total score ranging from 16 to 80. Higher scores indicate greater difficulties in emotion regulation and worse clinical outcomes.

    Measured: Baseline, end of the 7-day intervention, and 4 weeks post-intervention

  14. Sleep quality

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire evaluating sleep quality over the preceding month. The PSQI consists of seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: Baseline, end of the 7-day intervention, and 4 weeks post-intervention

  15. Resting-state EEG spectral power

    Resting-state EEG recordings will be used to assess changes in neural oscillatory activity following active or sham transcranial alternating current stimulation (tACS). Spectral power will be quantified in prespecified frequency bands.

    Measured: Baseline, immediately after the first intervention session, and end of the 7-day intervention

  16. Resting-state EEG functional connectivity

    Resting-state EEG functional connectivity will be assessed using a prespecified connectivity metric between selected brain regions or electrode pairs. The connectivity metric and its reporting scale will be specified before analysis.

    Measured: Baseline, immediately after the first intervention session, and end of the 7-day intervention

  17. Capsaicin-related EEG spectral power

    EEG spectral power will be assessed during the capsaicin-induced sensitization paradigm to characterize neural oscillatory activity associated with sustained experimentally induced pain. Spectral power will be quantified within predefined frequency bands.

    Measured: Baseline and end of the 7-day intervention

  18. Cyberball-related event-related potential (ERP) amplitudes

    ERP amplitudes will be assessed during the Cyberball social exclusion paradigm. EEG signals will be time-locked to predefined ball-tossing events, and amplitudes of prespecified ERP components will be quantified in microvolts (μV).

    Measured: Baseline and end of the 7-day intervention

  19. Heart rate (HR)

    Heart rate will be derived from electrocardiographic (ECG) recordings and expressed in beats per minute (bpm). Higher values indicate a faster heart rate.

    Measured: Baseline, immediately after the first intervention session, and end of the 7-day intervention

  20. Heart rate variability (HRV)

    Heart rate variability (HRV) will be assessed using the root mean square of successive differences between normal-to-normal intervals (RMSSD), derived from ECG recordings. RMSSD will be expressed in milliseconds (ms) and used as an index of cardiac vagal modulation.

    Measured: Baseline, immediately after the first intervention session, and end of the 7-day intervention

  21. Somatosensory evoked potential (SEP) N20 amplitude

    Somatosensory evoked potentials (SEPs) will be recorded to assess somatosensory cortical responses following active or sham transcranial alternating current stimulation (tACS). The amplitude of the early cortical N20 component will be quantified in microvolts (μV).

    Measured: Baseline, immediately after the first intervention session, and end of the 7-day intervention

  22. Peak pain intensity during capsaicin-induced sensitization

    Pain intensity will be assessed every 5 minutes during the capsaicin-induced sensitization paradigm using a 0-10 visual analog scale (VAS) administered via PsychoPy. Peak pain intensity is defined as the maximum VAS score recorded during the session. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater perceived pain intensity.

    Measured: Baseline and end of the 7-day intervention

  23. Social pain and affect after Cyberball social exclusion

    Assessed using the Post-Cyberball Questionnaire, administered immediately after the Cyberball paradigm (a 2-round, 3-minute per round, virtual ball-tossing game presented via PsychoPy). This measure includes two dimensions: Need Threat: Belonging, Self-esteem, Control, and Existence. Higher scores indicate greater perceived social need threat. Affective Response: Positive and Negative Affect. Higher negative affect scores indicate stronger negative emotions, higher positive affect scores indicate stronger positive emotions. A manipulation check is included to assess the perceived validity of the social exclusion.

    Measured: Baseline and end of the 7-day intervention

  24. Changes in positive and negative affect following Cyberball-induced social exclusion

    Emotional responses to social exclusion will be assessed immediately after the Cyberball paradigm using the International Positive and Negative Affect Schedule - Short Form (I-PANAS-SF). This self-report questionnaire measures positive affect (PA) and negative affect (NA) on a 5-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely). Higher PA scores indicate greater positive emotion, while higher NA scores indicate greater negative emotion. Changes in affective states will be analyzed to evaluate the emotional impact of Cyberball-induced social pain.

    Measured: Baseline and end of the 7-day intervention

  25. Emotion recognition accuracy during the eye-region reading task

    Emotion recognition accuracy will be assessed using an eye-region reading task. Participants will view images depicting different mental or emotional states and select the corresponding response. Accuracy will be calculated as the percentage of correct responses out of all valid trials, ranging from 0% to 100%. Higher scores indicate better recognition performance.

    Measured: Baseline and end of the 7-day intervention

  26. Eye-tracking behavioral measures during the eye-region reading task

    Eye-tracking recordings will be obtained during the eye-region reading task to assess visual attention and oculomotor behavior. Measures will include total fixation duration (milliseconds), fixation count (number of fixations), mean saccade amplitude (degrees of visual angle), and mean saccade velocity (degrees/second). These measures characterize different aspects of visual exploration and attentional processing.

    Measured: Baseline and end of the 7-day intervention

  27. Frequency and severity of adverse events during tACS intervention

    Assessed on 7 treatment days. Includes frequency, type, and severity of any adverse events reported by participants during tACS sessions.

    Measured: Seven treatment days

  28. Overall subjective tolerability of tACS intervention

    Overall subjective tolerability of transcranial alternating current stimulation (tACS) will be assessed using item 9 of the study-specific Subjective Tolerability Self-Assessment Questionnaire, administered after each treatment session during the 7-day intervention period. Participants rate their overall tolerability on a 5-point scale ranging from 1 (very poor) to 5 (very good). Higher scores indicate better subjective tolerability. The mean score across the 7 treatment days will be calculated for each participant.

    Measured: Seven treatment days

  29. Completion rate of tACS intervention sessions

    Proportion of scheduled tACS sessions completed by each participant during the 7-day intervention period. Higher completion rate indicates better overall acceptability and adherence.

    Measured: End of 7-day intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study start1 May 2025
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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
Model description
The present clinical protocol is designed as a double-blind, parallel, sham-controlled, randomized clinical trial.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919432
Sponsor's protocol ID
2024y1023
Status last verified
Oct 2026
First submitted
2 Apr 2025
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active-tACS (Nexalin Technology, Inc., Houston, TX, USA) in people with Non-suicidal Self-injury (NSSI), run by Shanghai Mental Health Center 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 10 inclusion and 9 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 2 Nov 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 TianHong Zhang, Doctor (13127577024, zhang_tianhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in NSSI frequency from baseline to 4-week post-intervention follow-up (time frame: Baseline (4-week retrospective period) and 4 weeks after intervention completion (assessed at post-intervention weeks 1, 2, and 4)). 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 2 Nov 2026.

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