Feasibility, Safety, and Preliminary Clinical Efficacy of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study

Обзор

This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) intervention for adolescent depression through a pilot clinical trial. The findings will inform the design and optimization of subsequent formal randomized controlled trials, providing essential evidence for their execution.

Подробное описание

This study is a randomized, double-blind, controlled pilot trial aimed at evaluating the feasibility, safety, acceptability, and preliminary efficacy trends of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of adolescent depression.

Adolescents diagnosed with Major Depressive Disorder (MDD) will be randomly assigned in a 1:1:1 ratio to one of three groups: the experimental target rTMS treatment group, the conventional target rTMS treatment group, and the sham stimulation group. All three groups will receive 4 weeks of rTMS stimulation (10 Hz, 120% RMT) or sham stimulation intervention, using the Blackdolphin TMS Robot (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 20 sessions (administered on weekdays) in total. The intervention frequency and procedure will remain consistent across all groups.

In the experimental target rTMS treatment group, participants will undergo MRI-guided identification of the left dorsolateral prefrontal cortex (DLPFC) region, where the voxel most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) will serve as the stimulation target. In the conventional target rTMS treatment group, participants will receive MRI-guided stimulation at the left DLPFC location. Participants in the sham stimulation group will receive a placebo treatment, simulating the rTMS procedure without generating an effective magnetic field output.

Primary outcomes include feasibility and acceptability indicators, such as recruitment, retention, adherence, assessment completion, and tolerability, as well as preliminary clinical efficacy. Secondary outcomes include anxiety, suicidal ideation and behaviour, and global clinical improvement. Safety will be monitored throughout.

Вмешательства

• Устройство Experimental target rTMS treatment
  Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site.
• Устройство Conventional target rTMS treatment
  participants will receive MRI-guided stimulation at the left DLPFC location.
• Устройство Sham stimulation treatment
  Participants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output.

Первичные конечные точки

• Recruitment Feasibility (Number of Participants Enrolled) [Срок оценки: 2 years]
• Intervention adherence (number of participants who completed the full 20 treatment sessions) [Срок оценки: Throughout the entire course of treatment (up to 1 month)]
• Retention Rate (Number of Participants Remaining at 6-Month Follow-up) [Срок оценки: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Response rate and remission rate of depressive symptoms [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Incidence of Adverse Events and Serious Adverse Events [Срок оценки: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]

Вторичные конечные точки (9)

• Change in BDI-II (Beck Depression Inventory-II) scores from baseline [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in HAMA score from baseline [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale) [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline [Срок оценки: Throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in RRS (Ruminative Responses Scale) [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]
• Change in PedsQL 4.0 score from baseline [Срок оценки: Baseline, throughout the entire course of treatment (up to 1 month) and follow-up (up to 6 months)]

Критерии участия

Критерии включения

• Age 12 - 18
• Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed through the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL), currently in a depressive episode
• Score≥40 on the CDRS-R
• Stable pharmacological treatment: At least 4 weeks of stable psychiatric medication use prior to enrollment, with continuation of the same psychiatric medication regimen throughout the study.

Критерии исключения

• Psychiatric comorbidities other than anxiety disorders
• Depression with psychotic symptoms
• Young Mania Rating Scale (YMRS) score >13
• A history of neurological disorders (e.g., epilepsy, brain injury) or severe somatic diseases (e.g., thyroid disorders, lupus, diabetes, pulmonary, hepatic, or renal impairment, major trauma)
• Patients currently using anticonvulsants or high-dose benzodiazepines
• A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments
• A history of alcohol or substance abuse or dependence
• Women who are pregnant or breastfeeding
• Current high suicide risk
• Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery
• Contraindications to MRI

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Публикации

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Идентификаторы

NCT: NCT07185438 · 1stChongqingCQMU___ZXY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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