Personalized iTBS in Real-World Clinical Settings for Schizophrenia

Официальное название

Efficacy of Personalized iTBS in Real-World Clinical Settings for Alleviating Schizophrenia Symptoms : A Randomized Single-Blind Trial

Обзор

This study is designed to determine whether neuronavigation-guided, personalized Intermittent Theta-Burst Stimulation (iTBS) can produce clinically benefits for patients with schizophrenia when delivered in real-world treatment settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant. The main questions it seeks to address are: Does the personalized iTBS target TMS protocol improve clinical symptoms in patients with schizophrenia within real-world treatment settings? What neural circuit changes, as assessed by functional MRI, occur following TMS treatment? Participants will: Undergo personalized,personalized iTBS target treatment daily for 2 weeks. Complete baseline and post-treatment assessments, including clinical symptom scales (PANSS, HAMA, HAMD) and neuropsychological tests (MoCA, DST, VFT, Stroop Test, and AVLT). Have structural and resting-state functional MRI scans before and after treatment. Be monitored for any treatment-related adverse events.

Подробное описание

Effective intervention is critical for reducing relapse risk, improving long-term prognosis, and lowering healthcare costs for schizophrenia.The present study therefore aims to assess whether neuronavigation-guided, individualized Intermittent Theta-Burst Stimulation (iTBS) can accelerate symptom improvement in schizophrenia when delivered in real-world clinical settings. By situating the intervention within real-world treatment settings-without imposing restrictions on concurrent pharmacotherapy-this trial seeks to generate evidence that is both scientifically rigorous and clinically relevant. Patients with schizophrenia will be prospectively recruited and received 2 weeks of iTBS treatment.

Before treatment, structural and resting-state functional MRI data wil be collected from each patient. Clinical symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). For patients experiencing auditory verbal hallucinations, the Auditory Hallucination Rating Scale (AHRS) will be also administered. Additionally, a battery of neuropsychological tests will be conducted, including the Montreal Cognitive Assessment (MoCA), Digit Span Test (DST), Verbal Fluency Test (VFT), Stroop Test, and Chinese Auditory Verbal Learning Test (AVLT).

After completing the 2-week iTBS treatment, clinical symptom severity, treatment-related adverse events wil be reassessed.

Вмешательства

• Другое Neuronavigation-guided individualized iTBS
  Participants will receive individualized iTBS for 14 consecutive days in addition to their usual medication regimen. iTBS parameters: 50 Hz bursts every 200 ms (5 Hz), 2s on/8s off, total 600 pulses per session;6 sessions/day (3 in morning, 3 in afternoon, 3600 pulses/day); 100% RMT intensity; Neuronavigation: Brainsight system (Rogue Research, Canada)

Первичные конечные точки

• The Positive and Negative Syndrome Scale (PANSS) [Срок оценки: baseline and week 2 (post-treatment)]

Вторичные конечные точки (4)

• Positive and Negative Syndrome Scale (PANSS) subscales [Срок оценки: baseline and week 2 (post-treatment)]
• Hamilton Anxiety Rating Scale (HAMA) [Срок оценки: baseline and week 2 (post-treatment)]
• Hamilton Depression Rating Scale (HAMD) [Срок оценки: baseline and week 2 (post-treatment)]
• Auditory Hallucination Rating Scale (AHRS) [Срок оценки: baseline and week 2 (post-treatment)]

Критерии участия

Критерии включения

• Aged 18-60 years, any gender
• Meets DSM-5 criteria for schizophrenia
• Antipsychotic medication change (initiation, dose adjustment, or switch) occurred within the past 3 days
• Capable of understanding the study and providing written informed consent Able to comply with study procedures and complete assessments

Критерии исключения

• Active suicidal ideation or behavior
• Major neurological disorders (e.g., epilepsy, organic brain lesions, severe head trauma)
• Contraindications to MRI or TMS (e.g., metal implants, pacemakers)
• Pregnancy or lactation
• Receipt of TMS or ECT within the past 6 months
• Judged by investigators to be unsuitable for participation

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Anhui Medical University — Хэфэй
• Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07176468 · AHMU-SCZ-RWTBS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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