DepressionNCT07047534

EEG-Triggered rTMS and Group Therapy for Adolescents With Depression and Self-Harm

A study testing Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS) and Group Therapy in people with Depression, run by The First Hospital of Hebei Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized controlled trial aims to evaluate the efficacy of real-time EEG-triggered repetitive transcranial magnetic stimulation (rTMS) combined with group therapy versus rTMS alone in adolescents (aged 12-18 years) diagnosed with depression and exhibiting recent self-harm behavior. Read more about this study

Who is it for?: Ages 12 to 18 years
Conditions the study is for: Depression
What is being tested?: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS) and Group Therapy
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteChina
Study dates: 1 Jun 2024to 31 Dec 2024
Phase: Interventional
Are there results?: None posted in the registry

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 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 12-18 years;
Diagnosis of major depressive disorder (MDD) according to the International Classification of Diseases, 10th Revision (ICD-10 F32);
Documented self-harm behavior within 2 weeks prior to enrollment (defined as deliberate self-injury without suicidal intent, e.g., cutting, burning);
Hamilton Depression Rating Scale (HAMD-24) score ≥17 at baseline;
Ability to complete self-report measures and participate in group therapy.

Who cannot join

Comorbid psychotic disorders (e.g., schizophrenia), bipolar disorder, or autism spectrum disorder;
History of neurological conditions (e.g., epilepsy, traumatic brain injury);
Current use of electroconvulsive therapy;
Refusal to provide informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000

Other trials in China

About this study

Official title: Real-time EEG-Triggered Transcranial Magnetic Stimulation Combined With Group Therapy for Adolescents With Depression and Self-Harm Behavior: A Randomized Controlled Trial

Read the detailed description

Adolescent depression is a prevalent and severe mood disorder, often comorbid with self-harm behavior, significantly impairing functioning. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique showing promise in depression treatment. Real-time EEG-triggered rTMS (rEEG-TMS) further refines this by synchronizing stimulation with individual neural rhythms, potentially enhancing precision and efficacy. Psychosocial interventions, such as group therapy, are crucial for adolescent mood disorders, offering peer support, emotional regulation skills, and cognitive restructuring. This study investigates whether combining rEEG-TMS with group therapy offers synergistic benefits over rEEG-TMS alone in adolescents with depression and self-harm.

This was a parallel-group randomized controlled trial. A total of 160 inpatients aged 12-18 years with a diagnosis of major depressive disorder (ICD-10 F32) and documented self-harm behavior within 2 weeks prior to enrollment were recruited. Participants were randomized 1:1 to either receive real-time EEG-triggered rTMS alone (control group, n=80) or real-time EEG-triggered rTMS plus group therapy (observation group, n=80). The rTMS intervention consisted of 20 sessions over 4 weeks (5 sessions/week), targeting the left dorsolateral prefrontal cortex (DLPFC) at 10 Hz, 110% of resting motor threshold, with 2000 pulses per session, triggered by the peak of the participant's ongoing θ-wave activity. The group therapy intervention, for the observation group, consisted of 8 semi-closed sessions (2 sessions/week for 4 weeks, 90 minutes/session) covering emotional recognition, cognitive restructuring, impulse control, and self-esteem building. Assessments were conducted at baseline and at 4 weeks post-intervention.

Conditions: Depression
Being tested: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS), Group Therapy
Keywords: Major Depressive Disorder, Self-Harm Behavior, Adolescent Depression, Transcranial Magnetic Stimulation, Group Therapy
Medical subject headings: Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Stimulation target: left dorsolateral prefrontal cortex (DLPFC; F3 electrode position, 10-20 EEG system); Frequency: 10 Hz; Intensity: 110% of resting motor threshold (RMT); Pulse number: 2000 pulses/session (20 trains of 100 pulses, 30-second inter-train interval); EEG triggering: Stimulation pulses synchronized to the peak of the participant's ongoing θ-wave (4-7 Hz) activity. Duration: 20 sessions over 4 weeks.
Group TherapyBehavioural
Semi-closed group therapy; 10 participants/group, 2 sessions/week, 90 minutes/session for 4 weeks (total 8 sessions). Content included: Sessions 1-2: Emotional recognition and expression training; Sessions 3-4: Cognitive restructuring; Sessions 5-6: Impulse control training; Sessions 7-8: Self-esteem building and future planning.

Study groups in NCT07047534
Study group	Role	What they receive
Real-time EEG-triggered rTMS Alone	Active comparator	Participants received 20 sessions of real-time EEG-triggered rTMS over 4 weeks (5 sessions/week). Receives: Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS)
Real-time EEG-triggered rTMS + Group Therapy	Experimental	Participants received identical rTMS (as the control group) plus semi-closed group therapy sessions. Receives: Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Group Therapy

What is being measured

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

Change in Hamilton Depression Rating Scale (HAMD-24) scores
The HAMD-24 is a clinician-rated scale to assess the severity of depressive symptoms. Higher scores indicate greater severity of depression. Change is calculated as score at week 4 minus score at baseline.
Measured: Baseline and Week 4 (post-intervention)

Secondary outcomes (8)

Change in Hamilton Anxiety Rating Scale (HAMA-14) scores
The HAMA-14 is a clinician-rated scale to assess the severity of anxiety symptoms. Higher scores indicate greater severity. Change is calculated as score at week 4 minus score at baseline.
Measured: Baseline and Week 4
Change in Suicide Probability Scale (SPS) scores
The SPS is a self-report measure assessing suicide risk. Scores range from 0-100, with higher scores indicating greater risk. Change is calculated as score at week 4 minus score at baseline.
Measured: Baseline and Week 4
Change in Modified Self-Harm Inventory (MSHI) scores
The MSHI assesses the frequency (0-4) and severity (0-4) of self-harm acts, with a total score ranging from 0-8. Higher scores indicate more severe self-harm behavior. Change is calculated as score at week 4 minus score at baseline.
Measured: Baseline and Week 4
Change in Event-Related Potential (ERP) P300 Latency
P300 latency (measured in milliseconds, ms) recorded during a visual Oddball paradigm at the Cz electrode. Shorter latency generally indicates faster cognitive processing speed. Change is calculated as value at week 4 minus value at baseline.
Measured: Baseline and Week 4
Change in Event-Related Potential (ERP) P300 Amplitude
P300 amplitude (measured in microvolts, μV) recorded during a visual Oddball paradigm at the Cz electrode. Larger amplitude generally indicates greater allocation of neural resources. Change is calculated as value at week 4 minus value at baseline.
Measured: Baseline and Week 4
Change in Resting-State EEG α (alpha) Power
Alpha power (8-12 Hz, measured in μV²) calculated over 3 minutes of eyes-closed resting state EEG. Change is calculated as value at week 4 minus value at baseline.
Measured: Baseline and Week 4
Change in Resting-State EEG θ (theta) Power
Theta power (4-7 Hz, measured in μV²) calculated over 3 minutes of eyes-closed resting state EEG. Change is calculated as value at week 4 minus value at baseline.
Measured: Baseline and Week 4
Change in Resting-State EEG θ/β (theta/beta) Ratio
Theta/beta ratio (beta=13-30 Hz) calculated over 3 minutes of eyes-closed resting state EEG. Change is calculated as value at week 4 minus value at baseline.
Measured: Baseline and Week 4

Timeline

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

1 Jun 202431 Dec 2024

First posted2 Jul 2025
Study start1 Jun 2024
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies 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: Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07047534
Sponsor's protocol ID: 20221425
Status last verified: Jun 2024
First submitted: 24 Jun 2025
Last updated: 2 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Liu H, Liu S, Yu M, Xin B, Liu Y. Real-time EEG-triggered transcranial magnetic stimulation combined with group therapy for adolescents with depression and self-harm behavior: A randomized controlled trial. J Affect Disord. 2026 Jan 1;392:120144. doi: 10.1016/j.jad.2025.120144. Epub 2025 Aug 26.
PubMed 40876639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-time EEG-Triggered Transcranial Magnetic Stimulation Combined With Group Therapy for Adolescents With Depression and Self-Harm Behavior: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07047534
Acronym / sponsor ID: 20221425
Conditions: Depression
Keywords: Major Depressive Disorder, Self-Harm Behavior, Adolescent Depression, Transcranial Magnetic Stimulation, Group Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: The First Hospital of Hebei Medical UniversityUniversity, hospital or other
Study start: 1 Jun 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 2 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Real-time EEG-triggered rTMS Alone	Active comparator	Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS)Participants received 20 sessions of real-time EEG-triggered rTMS over 4 weeks (5 sessions/week).
Real-time EEG-triggered rTMS + Group Therapy	Experimental	Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Group TherapyParticipants received identical rTMS (as the control group) plus semi-closed group therapy sessions.

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Age 12-18 years;
Diagnosis of major depressive disorder (MDD) according to the International Classification of Diseases, 10th Revision (ICD-10 F32);
Documented self-harm behavior within 2 weeks prior to enrollment (defined as deliberate self-injury without suicidal intent, e.g., cutting, burning);
Hamilton Depression Rating Scale (HAMD-24) score ≥17 at baseline;
Ability to complete self-report measures and participate in group therapy.

Key exclusion criteria (4 listed)

Comorbid psychotic disorders (e.g., schizophrenia), bipolar disorder, or autism spectrum disorder;
History of neurological conditions (e.g., epilepsy, traumatic brain injury);
Current use of electroconvulsive therapy;
Refusal to provide informed consent.

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
Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS)Stimulation target: left dorsolateral prefrontal cortex (DLPFC; F3 electrode position, 10-20 EEG system); Frequency: 10 Hz; Intensity: 110% of resting motor threshold (RMT); Pulse number: 2000 pulses/session (20 trains of 100 pulses, 30-second inter-train interval); EEG triggering: Stimulation pulses synchronized to the peak of the participant's ongoing θ-wave (4-7 Hz) activity. Duration: 20 sessions over 4 weeks.	Device	Real-time EEG-triggered rTMS + Group Therapy, Real-time EEG-triggered rTMS Alone
Group TherapySemi-closed group therapy; 10 participants/group, 2 sessions/week, 90 minutes/session for 4 weeks (total 8 sessions). Content included: Sessions 1-2: Emotional recognition and expression training; Sessions 3-4: Cognitive restructuring; Sessions 5-6: Impulse control training; Sessions 7-8: Self-esteem building and future planning.	Behavioural	Real-time EEG-triggered rTMS + Group Therapy

Primary outcome

Change in Hamilton Depression Rating Scale (HAMD-24) scores
Time frame: Baseline and Week 4 (post-intervention)
The HAMD-24 is a clinician-rated scale to assess the severity of depressive symptoms. Higher scores indicate greater severity of depression. Change is calculated as score at week 4 minus score at baseline.

8 secondary outcomes

Change in Hamilton Anxiety Rating Scale (HAMA-14) scores
Time frame: Baseline and Week 4
Change in Suicide Probability Scale (SPS) scores
Time frame: Baseline and Week 4
Change in Modified Self-Harm Inventory (MSHI) scores
Time frame: Baseline and Week 4
Change in Event-Related Potential (ERP) P300 Latency
Time frame: Baseline and Week 4
Change in Event-Related Potential (ERP) P300 Amplitude
Time frame: Baseline and Week 4
Change in Resting-State EEG α (alpha) Power
Time frame: Baseline and Week 4
Change in Resting-State EEG θ (theta) Power
Time frame: Baseline and Week 4
Change in Resting-State EEG θ/β (theta/beta) Ratio
Time frame: Baseline and Week 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
Derived from this study: PubMed 40876639Liu H, Liu S, Yu M, Xin B, Liu Y. Real-time EEG-triggered transcranial magnetic stimulation combined with group therapy for adolescents with depression and self-harm behavior: A randomized controlled trial. J Affect Disord. 2026 Jan 1;392:120144. doi: 10.1016/j.jad.2025.120144. Epub 2025 Aug 26.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 2 Jul 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Depression Rating Scale (HAMD-24) scores (time frame: Baseline and Week 4 (post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07047534, which also lists 1 linked publication.

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 Jul 2025.