Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT07047534
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG-Triggered rTMS and Group Therapy for Adolescents With Depression and Self-Harm
Sponsor:
The First Hospital of Hebei Medical University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. The primary outcome is the change in depression severity at 4 weeks.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: