Stereotactic Surgical Management of Dystonia: Efficacy and Safety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in Dystonia Severity (BFMDRS-Motor Score)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and clinical outcomes of stereotactic surgery (Deep Brain Stimulation or Radiofrequency Lesioning) in patients with dystonia.
The main questions it aims to answer are:
- Does stereotactic surgery improve dystonia severity as measured by the Burke-Fahn-Marsden Dystonia Rating Scale - Motor (BFMDRS-M)?
- Are the procedures safe, with an acceptable complication profile during follow-up?
Participants will:
- Undergo stereotactic surgery for dystonia (either Deep Brain Stimulation or Radiofrequency Lesioning, based on clinical indication).
- Be followed postoperatively for assessment of motor function and adverse events at the first postoperative week and six months after surgery.
详细描述
Detailed Description
Dystonia is a chronic movement disorder characterized by sustained or intermittent muscle contractions, resulting in abnormal postures, repetitive movements, and functional disability. Medical therapy often provides limited benefit, particularly in patients with severe or refractory forms of dystonia.
Stereotactic surgical approaches, including Deep Brain Stimulation (DBS) and Radiofrequency (RF) lesioning, have emerged as effective treatment options for carefully selected patients. DBS offers a reversible and adjustable method of neuromodulation, while RF lesioning provides a less resource-intensive option in settings where DBS may not be feasible.
The purpose of this study is to evaluate the clinical outcomes and safety of stereotactic surgical management in patients with dystonia treated at our center. All enrolled participants will undergo stereotactic surgery-either DBS implantation or RF lesioning-based on clinical indications and multidisciplinary decision-making.
Patients will be assessed preoperatively and followed postoperatively at standardized intervals, including the first postoperative week and at six months. The primary outcome is the change in dystonia severity as measured by the Burke-Fahn-Marsden Dystonia Rating Scale - Motor Subscale (BFMDRS-M). Secondary outcomes will include functional disability, quality of life, and perioperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with dystonia with at least 1-year duration since symptom onset.
- •Inadequate relief of dystonia following treatment with standard pharmacotherapies (e.g., levodopa, clonazepam, trihexyphenidyl, or baclofen) or botulinum toxin injections.
排除标准
- •Previous DBS surgery.
- •Underwent DBS combined with another surgical procedure for dystonia (e.g., lesioning or peripheral denervation).
- •Cognitive dysfunction or other neuropsychiatric disorders.
- •Progressive neurological conditions other than dystonia.
- •Coagulopathy or bleeding disorders.
研究组 & 干预措施
stereotactic surgery of dystonia
Patients with dystonia undergoing stereotactic surgical management (either Deep Brain Stimulation or Radiofrequency Lesioning), with choice of procedure determined by clinical indication.
干预措施: deep brain stimulation (Procedure)
结局指标
主要结局
Improvement in Dystonia Severity (BFMDRS-Motor Score)
时间窗: From baseline (within 4 weeks prior to surgery) to the first postoperative week and up to 6 months postoperatively.
Change in motor severity of dystonia as assessed by the Burke-Fahn-Marsden Dystonia Rating Scale - Motor Subscale (BFMDRS-M; range 0-120, higher scores = worse dystonia). The primary endpoint is the percent change from baseline to follow-up.
次要结局
未报告次要终点
研究者
Ahmed Mahmoud Mostafa
assistant lecture
Sohag University