Accelerated, Neuronavigated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Change in Avolition/Apathy Subscale Score
研究概览
简要总结
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.
The investigators 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, outcome assessors and treaters are blinded to treatment assignment. Care providers are blinded where feasible based on study procedures. Measures are in place to preserve blinding throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Active iTBS (BEAM-F3 Targeting)
Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using BEAM-F3 targeting.
干预措施: BEAM-F3 Intermittent theta burst stimulation (Device)
Sham iTBS
Participants receive sham iTBS over five consecutive days (ten sessions/day) using the same session structure and procedures as active treatment.
干预措施: Sham Intermittent Theta Burst Stimulation (Device)
Active iTBS (Neuronavigated Targeting)
Participants receive iTBS over five consecutive days (ten sessions/day) targeting the left dorsolateral prefrontal cortex using neuronavigation-guided targeting.
干预措施: Neuronavigated Intermittent Theta Burst Stimulation (Device)
结局指标
主要结局
Change in Avolition/Apathy Subscale Score
时间窗: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in score on the Avolition/Apathy subscale of the Scale for the Assessment of Negative Symptoms (SANS). The SANS Avolition/Apathy subscale ranges from 0 to 25, with higher scores indicating greater negative symptom severity.
Change in Scale for the Assessment of Negative Symptoms Total Score
时间窗: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in total score on the Scale for the Assessment of Negative Symptoms (SANS). Total scores range from 0 to 125, with higher scores indicating greater negative symptom severity.
Change in Brief Negative Symptom Scale Total Score
时间窗: Baseline to 1 week, 1 month, and 3 months post-treatment
Change in total score on the Brief Negative Symptom Scale (BNSS). Total scores range from 0 to 78, with higher scores indicating greater negative symptom severity.
Effect of Targeting Method on Negative Symptoms
时间窗: Baseline to 1 week, 1 month, and 3 months post-treatment
Difference in change in negative symptom severity between targeting methods, as measured by negative symptom outcomes.
次要结局
- Change in Affective Processing(Baseline to 1 week, 1 month, and 3 months post-treatment)
- Change in Social Appraisal(Baseline to 1 week, 1 month, and 3 months post-treatment)
- Change in Cognitive Performance(Baseline to 1 week, 1 month, and 3 months post-treatment)
- Change in Montgomery-Åsberg Depression Rating Scale Score(Baseline to 1 week, 1 month, and 3 months post-treatment)
- Change in Calgary Depression Scale for Schizophrenia Score(Baseline to 1 week, 1 month, and 3 months post-treatment)
- Change in Social and Occupational Functioning Assessment Scale Score(Baseline to 1 week, 1 month, and 3 months post-treatment)
研究者
David Benrimoh
NeuroPsychiatrist
Douglas Mental Health University Institute