Depression DisordersNCT07152925
The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury
A study testing Beta-frequency transcranial alternating current stimulation in people with Depression Disorders and Non-suicidal Self-injury, run by Anhui Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Depression Disorders, Non-suicidal Self-injury
- What is being tested?
- Beta-frequency transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 May 2026
- 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
- 1) 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); 2) Aged 12-18 years; 3) Right-handed; 4) Possess formal education experience sufficient to comprehend experimental protocols; 5) Normal or corrected-to-normal binocular visual acuity; 6) Voluntarily participate with legal guardians providing written informed consent.
Who cannot join
- 1) Montreal Cognitive Assessment (MoCA) score < 26; 2) History of suicide attempt(s); 3) Medical history of epilepsy, brain surgery, intracranial tumors, metal implants in the skull, or clinically significant head trauma; 4) History of substance use disorder, brain injury, severe somatic diseases, psychiatric disorders, or comorbid DSM-5 psychiatric conditions; 5) Prior receipt of transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or repetitive transcranial magnetic stimulation (rTMS) within the past 3 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, Anhui Medical University
Hefei, Anhui
Lei Zhang, doctor, +86 138 6612 9450, anyipsychology@163.com
About this study
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:
- Can beta-band tACS significantly reduce the frequency of self-injury and scores on impulsivity scales in adolescents with NSSI?
- What discomfort or medical issues may participants experience during tACS intervention?
Read more
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:
- Receive two sessions of either tACS or sham stimulation daily, spaced 4 hours apart, for 7 consecutive days (14 sessions in total).
- Undergo scale assessments, behavioral tasks, and eye-tracking tests before and after the intervention.
- Record any self-injury episodes and adverse reactions, with continuous monitoring and psychological support provided by a professional team.
- Conditions
- Depression Disorders, Non-suicidal Self-injury
- Being tested
- Beta-frequency transcranial alternating current stimulation, sham beta-frequency transcranial alternating current stimulation
- Keywords
- Depression, non-suicidal self-injury, transcranial alternating current stimulation
- Medical subject headings
- Self-Injurious Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-frequency transcranial alternating current stimulationDevice
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).
sham beta-frequency transcranial alternating current stimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Active stimulation: deliver 20 minutes of beta-band tACS intervention. Receives: Device: Beta-frequency transcranial alternating current stimulation |
| 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. Receives: Device: sham beta-frequency 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Mar 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Meiling, Anhui Medical University
- Investigators
- Lei Zhang, doctor, Study director, School of Mental Health and Psychological Sciences, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152925
- Sponsor's protocol ID
- AHMU-beta-band-tACS-NSSI
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury
- ClinicalTrials.gov ID
- NCT07152925
- Acronym / sponsor ID
- AHMU-beta-band-tACS-NSSI
- Conditions
- Depression Disorders, Non-suicidal Self-injury
- Keywords
- Depression, non-suicidal self-injury, transcranial alternating current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Sep 2025 (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.
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:
- Can beta-band tACS significantly reduce the frequency of self-injury and scores on impulsivity scales in adolescents with NSSI?
- What discomfort or medical issues may participants experience during tACS intervention?
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:
- Receive two sessions of either tACS or sham stimulation daily, spaced 4 hours apart, for 7 consecutive days (14 sessions in total).
- Undergo scale assessments, behavioral tasks, and eye-tracking tests before and after the intervention.
- Record any self-injury episodes and adverse reactions, with continuous monitoring and psychological support provided by a professional team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Device: Beta-frequency transcranial alternating current stimulationActive stimulation: deliver 20 minutes of beta-band tACS intervention. |
| Control group | Sham comparator | Device: sham beta-frequency transcranial alternating current stimulationSham 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. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1) 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); 2) Aged 12-18 years; 3) Right-handed; 4) Possess formal education experience sufficient to comprehend experimental protocols; 5) Normal or corrected-to-normal binocular visual acuity; 6) Voluntarily participate with legal guardians providing written informed consent.
Key exclusion criteria (1 listed)
- 1) Montreal Cognitive Assessment (MoCA) score < 26; 2) History of suicide attempt(s); 3) Medical history of epilepsy, brain surgery, intracranial tumors, metal implants in the skull, or clinically significant head trauma; 4) History of substance use disorder, brain injury, severe somatic diseases, psychiatric disorders, or comorbid DSM-5 psychiatric conditions; 5) Prior receipt of transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or repetitive transcranial magnetic stimulation (rTMS) within the past 3 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 |
|---|---|---|
| Beta-frequency transcranial alternating current stimulationActive 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). | Device | Experimental group |
| sham beta-frequency transcranial alternating current stimulationSham 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 | Control group |
Primary outcome
Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
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.
UPPS-P Impulsive Behavior Scale (UPPS-P)
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
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.
Brief Barratt Impulsiveness Scale (BBIS)
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
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.
Eye movement index-fixation time
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
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.
Eye movement index-fixation counts
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
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.
Balloon Analog Risk Task-Total number of Balloon explosions
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
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.
6 secondary outcomes
Hamilton Depression Scale (HAMD-17) score
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
Hamilton Anxiety Scale (HAMA-14) score
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
the score of Moca
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
the score of TAS-20
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
the score of ERQ
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
the score of PANSI
Time frame: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.
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 3 Sep 2025.
- 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.
Lei Zhang, doctor study director
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 Beta-frequency transcranial alternating current stimulation in people with Depression Disorders and 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 1 inclusion and 1 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 3 Sep 2025. 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 Meiling Wang, bachelor (+86 136 4707 0027, 1605280093@qq.com), 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: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.). The study lists 6 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 3 Sep 2025.