Deep Brain Stimulation Effects in Dystonia: Time Course of Electrophysiological Changes in Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Unified Dystonia Rating Scale (UDRS)
研究概览
简要总结
Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.
详细描述
The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series. The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient gives an informed consent.
- •Patient is over 18 years of age.
- •Having a diagnosis of a primary dystonia confirmed by a trained movement disorders neurologist;
- •Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;
排除标准
- •Having alternative diagnoses to a primary dystonic syndrome;
- •Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease);
- •Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
- •History of prior resectivebrain surgery (e.g. tumor resection);
- •Not being a DBS candidate;
- •Selection of alternative targets to conventional GPi;
- •Receiving unilateral implants
- •Having a higher surgical risk that precludes patient from having standard intraoperative mapping.
结局指标
主要结局
Unified Dystonia Rating Scale (UDRS)
时间窗: 12 months
A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)
Toronto Western Spasmodic Torticollis Rating Scale
时间窗: 12 months
A clinical scale of dystonia severity (0-4, 0:no symptoms, 4:extreme)
Burke-Fahn-Marsden Dystonia Rating Scale
时间窗: 12 months
A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)
次要结局
未报告次要终点