Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

Официальное название

Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia

Обзор

The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time. Participants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation. We want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes Participants will be asked to complete clinical interviews and questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment This study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.

Подробное описание

Negative symptoms of schizophrenia, including diminished motivation, reduced emotional expression, and impaired social functioning, are a major contributor to long-term disability and remain inadequately treated by existing interventions. Repetitive transcranial magnetic stimulation targeting the left dorsolateral prefrontal cortex has demonstrated potential benefit for negative symptoms, but conventional treatment schedules often require multiple weeks of daily sessions, which may limit feasibility in this population.

Accelerated neuromodulation therapy delivers multiple stimulation sessions per day over a condensed time period and may improve accessibility, adherence, and tolerability. This pilot study evaluates an accelerated iTBS protocol delivered over five consecutive days in individuals with schizophrenia spectrum disorders who exhibit clinically significant negative symptoms.

Participants are randomized to receive either active neuromodulation therapy or sham stimulation. In addition, the study evaluates two approaches to stimulation targeting. Targeting approach is assigned according to study procedures designed to preserve participant and rater blinding.

All participants undergo baseline clinical, behavioral, and functional assessments, followed by the accelerated treatment protocol and post-treatment follow-up assessments. Primary outcomes focus on changes in negative symptom severity, while secondary outcomes assess depressive symptoms, functional outcomes, and task-based behavioral measures.

Вмешательства

• Устройство Neuronavigated Intermittent Theta Burst Stimulation
  Neuronavigated intermittent theta burst stimulation (iTBS) is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil targeting the left dorsolateral prefrontal cortex. Individualized stimulation targets are identified using functional MRI data and are imported into a neuronavigation system to guide coil positioning and orientation throughout treatment. Treatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation se
• Устройство BEAM-F3 Intermittent theta burst stimulation
  BEAM-F3 intermittent theta burst stimulation (iTBS) is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil targeting the left dorsolateral prefrontal cortex. Stimulation targets are identified according to the BEAM-F3 procedure. Treatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Each iTBS session is delivered at an intensity corresponding to 110% of the participant's resting motor thr
• Устройство Sham Intermittent Theta Burst Stimulation
  Sham intermittent theta burst stimulation is delivered using a transcranial magnetic stimulation device with a figure-of-eight coil positioned over the left dorsolateral prefrontal cortex. Coil placement, session structure, and treatment schedule are identical to those used for active stimulation. Treatment is delivered over five consecutive days using an accelerated schedule consisting of ten stimulation sessions per day. Sham stimulation is administered using procedures designed to mimic the

Первичные конечные точки

• Change in Avolition/Apathy Subscale Score [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Change in Scale for the Assessment of Negative Symptoms Total Score [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Change in Brief Negative Symptom Scale Total Score [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Effect of Targeting Method on Negative Symptoms [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]

Вторичные конечные точки (6)

• Change in Affective Processing [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Change in Social Appraisal [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Change in Cognitive Performance [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Change in Montgomery-Åsberg Depression Rating Scale Score [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Change in Calgary Depression Scale for Schizophrenia Score [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]
• Change in Social and Occupational Functioning Assessment Scale Score [Срок оценки: Baseline to 1 week, 1 month, and 3 months post-treatment]

Критерии участия

Критерии включения

• Confirmed diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
• Duration of illness ≥ 6 months
• Clinically significant negative symptoms
• Must have been on a stable pharmacological treatment for at least 4 weeks before entering the study
• Clinicians will confirm that patients' negative and positive symptoms have been stable per their clinical opinion for at least 3 months.
• Participants must be able to provide informed consent
• Ability to undergo MRI scanning

Критерии исключения

• Pregnancy, lactation, or an intrauterine device
• History of electroconvulsive therapy (ECT) in the past 6 months
• Use of licit or illicit substances (excluding cannabis) during the week of treatment and in the 24 hours prior to fMRI scans
• Contraindications for TMS
• Previous treatment with rTMS
• Documented history of significant intellectual disability
• Primary diagnosis of psychotic disorder secondary to a medical condition or substance-induced psychosis.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 3 центра

• Institut Universitaire en Santé Mentale de Montréal — Montreal
• Institut universitaire de santé mentale de Québec - Centre de recherche CERVO — Québec
• McGill Lab for Computational Psychiatry and Translation - Burland Pavilion 6875 Boulevard — Verdun

Идентификаторы

NCT: NCT07428460 · MP-18-2025-1206 · 8401470ASMQ · CIHR-8401550

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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