Temporal Interference StimulationNCT07554755
TIS for NSSI in Adolescent Depression
A study testing Active Temporal Interference Stimulation (TIS) in people with Temporal Interference Stimulation and Non Suicidal Self Injury, run by The Second Hospital of Anhui Medical University at 1 site in China.
Trial summary
Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive… Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Temporal Interference Stimulation, Non Suicidal Self Injury, Major Depressive Disorder
- What is being tested?
- Active Temporal Interference Stimulation (TIS)
- 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
- 30 Apr 2026to 31 Jan 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 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
- Patients aged 12-22 years with at least one guardian to monitor them for 3 months
- HAMD-17 Total score ≥18
- Patients who had two or more non-suicidal self-injury behaviors meeting the 5.DSM-5 diagnostic criteria in the 2 weeks before admission (NSSI behavior of more than 5 days in the past year)
- 6.Obtain informed consent from patients and guardians
- -
Who cannot join
- Substance abusers such as psychoactive drugs or alcohol.
- Severe physical disability and unable to complete follow-up.
- Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
- Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
- Unable to read, understand and complete the assessment or to cooperate with the investigators.
- Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for TIS.
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- Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
- Other examination abnormalities considered to be inappropriate by investigators.
- -
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
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Yanghua Tian, PhD, 0551 6599 7278, tianyh@ahmu.edu.cn
Hongping Wang, +86-18256001073, medstuwhp@126.com
About this study
Official title: Efficacy and Safety of Temporal Interference Stimulation on Non-suicidal Self-injury Behaviors in Adolescents With Depression
Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive disorder(MDD).
Read the detailed description
The study will evaluate the efficacy and safety of TIS in depressive patients with NSSI behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks, 8 weeks after treatment. 60 inpatients will be randomized to receive active or sham interventions administered to the right subgenual anterior cingulate cortex. The treatment will apply TIS involving 2x daily at 30 minutes for 5-7 days.
Changes in mood from baseline to the end of the study will be measured with The Hamilton Rating Scale for Depression-17 item (HAMD-17), Hamilton Anxiety Scale (HAMA). Non-suicidal self injury will be assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ). Suicidal ideation and behaviors assessments will be measured with Beck Suicidal Scale Inventory (BSI). Changes in somatic symptom severity from baseline to the end of the study will be measured with the Patient Health Questionnaire-15 (PHQ-15). Sleep quality and disturbances will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Insomnia severity will be evaluated using the Insomnia Severity Index (ISI). Ruminative thinking styles will be measured with the Ruminative Responses Scale (RRS). Impulsivity and aggression assessments will be measured with the Barratt Impulsiveness Scale (BIS) and the Buss-Perry Aggression Questionnaire (BPAQ), respectively. Additionally, pain-related attention and hypervigilance will be assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ). Adverse event record form (AERF) will be used to appraise the safety of TIS treatment. Changes of brain structure and brain activities will be acquired by pre and post-interventional magnetic resonance imaging (MRI).
- Being tested
- Active Temporal Interference Stimulation (TIS), Sham Temporal Interference Stimulation (TIS)
- Medical subject headings
- Self-Injurious Behavior, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Temporal Interference Stimulation (TIS)Device
Active stimulation to the right subgenual anterior cingulate cortex; 2 sessions per day, 30 minutes per session, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end, for 5-7 days.
Sham Temporal Interference Stimulation (TIS)Device
Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.
| Study group | Role | What they receive |
|---|---|---|
| real stimulation | Active comparator | Participants will receive active TIS 10 to 14 times. Receives: Device: Active Temporal Interference Stimulation (TIS) |
| sham stimulation | Sham comparator | Participants will receive sham TIS 10 to 14 times. Receives: Device: Sham Temporal Interference Stimulation (TIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ)
Containing one subscale evaluating the frequency and primary methods of self-injury behaviors in patients over the past 2 weeks,and one subscale ranging from 0 to 10 to assess the self-injurious thoughts, with 0 indicating "not at all" and 10 indicating "very strongly."
Measured: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Range from 0-52, higher score indicates more severe symptoms
Measured: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Secondary outcomes (11)
Changes in Hamilton Anxiety Scale (HAMA)
Range from 0-56, higher score indicates more severe symptoms
Measured: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Change in the Patient Health Questionnaire-15 (PHQ-15)
Range from 0 to 30, higher score indicates more severe somatic symptoms.
Measured: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Changes in Insomnia Severity Index (ISI)
Range from 0 to 28. Higher scores indicate more severe insomnia symptoms.
Measured: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Changes in Ruminative Responses Scale (RRS)
Range from 22 to 88. Higher scores indicate higher levels of ruminative thinking.
Measured: Baseline, the day after the end of TIS
Changes in Beck Suicidal Scale Inventory (BSI)
Range from 0- 38, higher score indicates more severe suicide ideation.
Measured: Baseline, the day after the end of TIS
Chinese version of the Barratt Impulsiveness Scale
Total score ranges from 0 to 100. It is converted from a 30-item raw score based on a 5-point scale. Higher scores indicate greater levels of impulsivity.
Measured: Baseline, the day after the end of TIS
Changes in the Chinese version of the Buss & Perry Aggression Questionnaire
Total score ranges from 0 to 100. It is mathematically converted from the sum of the raw item scores. Higher scores indicate greater levels of aggression.
Measured: Baseline, the day after the end of TIS
Changes in Pain Vigilance and Awareness Questionnaire (PVAQ)
Range from 0 to 80. Higher scores indicate greater pain-related attention and hypervigilance.
Measured: Baseline, the day after the end of TIS
Changes of high-resolution T1-weighted anatomical images
T1-weighted images will be acquired using 3D inversion recovery-prepared fast spoiled gradient-echo sequences.
Measured: Baseline, the day after the end of TIS
Changes of blood oxygenation level dependent (BOLD) functional imaging signals
Resting-state MRI (rs-MRI) will be used to exam the change of brain function.
Measured: Baseline, the day after the end of TIS
Changes of Diffusion Tensor Imaging
Diffusion Tensor Imaging (DTI) will be performed using diffusion-weighted echo planar imaging sequences.
Measured: Baseline, the day after the end of TIS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal Interference StimulationStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanghua Tian, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554755
- Sponsor's protocol ID
- AHMU-TIS-NSSI
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Temporal Interference Stimulation on Non-suicidal Self-injury Behaviors in Adolescents With Depression
- ClinicalTrials.gov ID
- NCT07554755
- Acronym / sponsor ID
- AHMU-TIS-NSSI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 28 Apr 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.
Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive disorder(MDD).
Detailed description
The study will evaluate the efficacy and safety of TIS in depressive patients with NSSI behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 weeks, 8 weeks after treatment. 60 inpatients will be randomized to receive active or sham interventions administered to the right subgenual anterior cingulate cortex. The treatment will apply TIS involving 2x daily at 30 minutes for 5-7 days.
Changes in mood from baseline to the end of the study will be measured with The Hamilton Rating Scale for Depression-17 item (HAMD-17), Hamilton Anxiety Scale (HAMA). Non-suicidal self injury will be assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ). Suicidal ideation and behaviors assessments will be measured with Beck Suicidal Scale Inventory (BSI). Changes in somatic symptom severity from baseline to the end of the study will be measured with the Patient Health Questionnaire-15 (PHQ-15). Sleep quality and disturbances will be assessed by the Pittsburgh Sleep Quality Index (PSQI). Insomnia severity will be evaluated using the Insomnia Severity Index (ISI). Ruminative thinking styles will be measured with the Ruminative Responses Scale (RRS). Impulsivity and aggression assessments will be measured with the Barratt Impulsiveness Scale (BIS) and the Buss-Perry Aggression Questionnaire (BPAQ), respectively. Additionally, pain-related attention and hypervigilance will be assessed by the Pain Vigilance and Awareness Questionnaire (PVAQ). Adverse event record form (AERF) will be used to appraise the safety of TIS treatment. Changes of brain structure and brain activities will be acquired by pre and post-interventional magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real stimulation | Active comparator | Device: Active Temporal Interference Stimulation (TIS)Participants will receive active TIS 10 to 14 times. |
| sham stimulation | Sham comparator | Device: Sham Temporal Interference Stimulation (TIS)Participants will receive sham TIS 10 to 14 times. |
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 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
- Patients aged 12-22 years with at least one guardian to monitor them for 3 months
- HAMD-17 Total score ≥18
- Patients who had two or more non-suicidal self-injury behaviors meeting the 5.DSM-5 diagnostic criteria in the 2 weeks before admission (NSSI behavior of more than 5 days in the past year)
- 6.Obtain informed consent from patients and guardians
Key exclusion criteria (9 listed)
- Substance abusers such as psychoactive drugs or alcohol.
- Severe physical disability and unable to complete follow-up.
- Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
- Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
- Unable to read, understand and complete the assessment or to cooperate with the investigators.
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 |
|---|---|---|
| Active Temporal Interference Stimulation (TIS)Active stimulation to the right subgenual anterior cingulate cortex; 2 sessions per day, 30 minutes per session, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end, for 5-7 days. | Device | real stimulation |
| Sham Temporal Interference Stimulation (TIS)Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation. | Device | sham stimulation |
Primary outcome
Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ)
Time frame: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Containing one subscale evaluating the frequency and primary methods of self-injury behaviors in patients over the past 2 weeks,and one subscale ranging from 0 to 10 to assess the self-injurious thoughts, with 0 indicating "not at all" and 10 indicating "very strongly."
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Time frame: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Range from 0-52, higher score indicates more severe symptoms
11 secondary outcomes
Changes in Hamilton Anxiety Scale (HAMA)
Time frame: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Change in the Patient Health Questionnaire-15 (PHQ-15)
Time frame: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Changes in Insomnia Severity Index (ISI)
Time frame: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS
Changes in Ruminative Responses Scale (RRS)
Time frame: Baseline, the day after the end of TIS
Changes in Beck Suicidal Scale Inventory (BSI)
Time frame: Baseline, the day after the end of TIS
Chinese version of the Barratt Impulsiveness Scale
Time frame: Baseline, the day after the end of TIS
Changes in the Chinese version of the Buss & Perry Aggression Questionnaire
Time frame: Baseline, the day after the end of TIS
Changes in Pain Vigilance and Awareness Questionnaire (PVAQ)
Time frame: Baseline, the day after the end of TIS
Changes of high-resolution T1-weighted anatomical images
Time frame: Baseline, the day after the end of TIS
Changes of blood oxygenation level dependent (BOLD) functional imaging signals
Time frame: Baseline, the day after the end of TIS
Changes of Diffusion Tensor Imaging
Time frame: Baseline, the day after the end of TIS
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 28 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Temporal Interference Stimulation (TIS) in people with Temporal Interference Stimulation and Non Suicidal Self Injury, run by The Second Hospital of 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 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 28 Apr 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 Yanghua Tian, PhD (+86-13955188448, tianyh@ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Adolescent Non-Suicidal Self-Injurious Behavior Assessment Questionnaire (ANSAQ) (time frame: Baseline, the day after the end of TIS, 2 weeks after the end of TIS, 4 weeks after the end of TIS, 8 weeks after the end of TIS). The study lists 2 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 28 Apr 2026.