An interventional study of Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS) and Group Therapy in Depression, sponsored by The First Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by The First Hospital of Hebei Medical University · Not applicable, Interventional, and Treatment
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. The primary outcome is the change in depression severity at 4 weeks.
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.
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This study's enrollment of 160 is above the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Participants received 20 sessions of real-time EEG-triggered rTMS over 4 weeks (5 sessions/week).
Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS)
Participants received identical rTMS (as the control group) plus semi-closed group therapy sessions.
Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS) · Behavioral: Group Therapy
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.
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.
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.
Time frame: Baseline and Week 4 (post-intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 4
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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The First Hospital of Hebei Medical University