Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimulation (rfTMS) Delivered Through a Multi-Channel Deep Coil Stimulation System in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Blinding response distribution
研究概览
简要总结
This study evaluates the effectiveness of an improved blinding method using rotational field transcranial magnetic stimulation (rfTMS) delivered through a multi-channel deep coil system (Brainsway, Jerusalem, Israel). Healthy volunteers receive a single session of either Active or Sham stimulation over the medial prefrontal cortex. The study assesses whether the Sham condition sufficiently masks the sensory characteristics of Active stimulation. Findings will support the optimization of blinding procedures for future deep TMS (dTMS) trials.
详细描述
Effective Sham blinding is essential for the validity of deep TMS (dTMS) clinical trials. Existing Sham methods often fail to adequately mimic the sensory experience of Active stimulation, allowing participants to infer their treatment allocation. This prospective, randomized, double-blind study examines blinding integrity using rotational field transcranial magnetic stimulation (rfTMS) implemented on a multi-channel deep coil system (Brainsway, Jerusalem, Israel). Participants receive either Active stimulation or a Sham condition matched for coil placement, auditory and tactile experience but without inducing field in the brain. Results will inform the design of future dTMS studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Healthy adults aged 18-65
- •Hebrew or English speakers
- •No neurological, psychiatric, or developmental disorders
- •No contraindications for TMS
- •Able to provide informed consent
排除标准
- •History of seizure
- •Metal implants in the head or neck
- •Pacemakers or implanted stimulators
- •Pregnancy
- •Current psychoactive medication affecting seizure threshold
- •Any contraindication listed in standard TMS safety guidelines
结局指标
主要结局
Blinding response distribution
时间窗: Immediately post-session
Distribution of participant responses on a five-scale blinding questionnaire indicating perceived stimulation type (Active vs Sham), reported as the proportion of participants selecting each response category.
次要结局
未报告次要终点
研究者
Iuly Treger MD
Director of Rehabilitation Department
Soroka University Medical Center