Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

NCT ID: NCT06919432

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-09-30

Brief Summary

In order to assess the clinical efficacy of triple-daily 15mA-tACS stimulation by comparing the effects of active and sham tACS interventions on driving improvements in adolescent Nonsuicidal Self-Injury(NSSI), participants will be randomly assigned to either the active or sham tACS group. This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. The key hypothesis is that triple-daily 15mA-tACS stimulation will enhance clinical recovery compared to sham stimulation.

Detailed Description

Recognizing the clinical shortcomings of traditional methods for adolescent NSSI, study objective is to establish evidence supporting the efficacy of a triple-daily 15mA-tACS stimulation regimen targeting the forehead and both mastoids. This intervention will be administered five days a week over a four-week treatment period, with the aim of eliciting substantial clinical improvements in adolescent NSSI compared to a sham intervention. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days. Following the completion of treatment, participants will undergo follow-up observations every 7 days for 4 weeks. EEG and ECG recordings will be obtained at baseline, on day 1 after the first session, at the end of the 2-week intervention period (after 40 sessions), and at the 6-week follow-up. Throughout the sessions, all evaluations will be conducted under standardized conditions.

Conditions

Self-Injurious Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

the active-tACS group

This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days.

Group Type: EXPERIMENTAL

Active-tACS

Intervention Type: DEVICE

Participants were comfortably positioned on a lounge chair and received alternating current stimulation using an FDA-approved tACS device (Nexalin Technology, Inc., Houston, TX, USA). Electrodes were evenly placed across the forehead and mastoid regions. Trained nurses administered the tACS according to standardized protocols.

the sham-tACS group

Participants in the sham-tACS group will undergo the same protocol, utilizing a sham tACS incapable of delivering active stimulation. They will be kept unaware of their assigned treatment.

Group Type: SHAM_COMPARATOR

Sham-tACS

Intervention Type: DEVICE

The sham tACS device will resemble the active stimulation device in appearance, weight, size, color, and odor, ensuring indistinguishability for the patients. Throughout the entire intervention period, each participant will be allocated to the same tACS device, regardless of whether it delivers active or sham stimulation.

Interventions

Active-tACS

Participants were comfortably positioned on a lounge chair and received alternating current stimulation using an FDA-approved tACS device (Nexalin Technology, Inc., Houston, TX, USA). Electrodes were evenly placed across the forehead and mastoid regions. Trained nurses administered the tACS according to standardized protocols.

Intervention Type: DEVICE

Sham-tACS

The sham tACS device will resemble the active stimulation device in appearance, weight, size, color, and odor, ensuring indistinguishability for the patients. Throughout the entire intervention period, each participant will be allocated to the same tACS device, regardless of whether it delivers active or sham stimulation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of NSSI based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria section 3 diagnostic criteria.
• Five or more NSSI episodes in the past year and at least one NSSI episode in the past month.
• Age between 12 and 21 years.
• Informed consent from parents or legal guardians.
• Informed consent from participants aged 15 years and above.

Exclusion Criteria

• Current or history of organic brain disorders or neurological disorders.
• Elevated or imminent suicidal risk, as assessed by clinicians during routine screening.
• Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, TMS, transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments.
• Presence of cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain.
• Previous or current use of psychotropic medication.
• Pregnancy or lactation.
• Participation in another concurrent clinical trial.
• Refusal to provide informed consent to participate in the trial.
• Other circumstances deemed unsuitable for participation by researchers.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Tianhong ZHANG

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TianHong Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

TianHong Zhang, Doctor

Role: CONTACT

zhang_tianhong@126.com

13127577024

Facility Contacts

TianHong Zhang, Doctor

Role: primary

zhang_tianhong@126.com

13127577024

Other Identifiers

2024y1023

Identifier Type: -

Identifier Source: org_study_id