Prediction of Deep Brain Stimulation (DBS) Efficacy in Patients With Dystonia Based on Preoperative Wearable Gait Analysis: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between Baseline Gait Features and BFMDRS Improvement
研究概览
简要总结
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
详细描述
This study aims to investigate whether preoperative gait characteristics, measured by wearable sensors, can predict the clinical outcomes of Deep Brain Stimulation (DBS) in patients with dystonia. Participants scheduled for DBS surgery will undergo gait analysis using wearable sensors before the procedure. Clinical assessments, including the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) and the SF-36 Health Survey, will be conducted preoperatively and postoperatively to evaluate surgical efficacy and quality of life. The study seeks to identify gait biomarkers that correlate with optimal DBS response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with primary or isolated dystonia.
- •Scheduled to undergo bilateral Deep Brain Stimulation (DBS) surgery.
- •Able to walk independently or with assistance (sufficient to perform gait analysis).
- •Willing to participate and sign informed consent.
排除标准
- •History of other neurological disorders affecting gait (e.g., stroke, severe neuropathy).
- •Significant orthopedic issues preventing gait assessment.
- •Cognitive impairment preventing cooperation with study procedures.
- •Previous functional neurosurgery.
结局指标
主要结局
Correlation between Baseline Gait Features and BFMDRS Improvement
时间窗: Through study completion, up to 6 months
次要结局
- Change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) Score(Baseline (pre-operative) and 6 months post-operative)
- Change in SF-36 Quality of Life Score(Baseline (pre-operative) and 6 months post-operative)
- Gait Characteristics (Spatio-temporal parameters)(Baseline (pre-operative))