Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Reaction Time
研究概览
简要总结
This study evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS).
详细描述
Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 40 and 70 years of age,
- •Ability to provide informed consent,
- •Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
- •Disease duration of at least 4 years,
- •Treated with bilateral STN DBS for at least 3 months prior to study enrollment.
排除标准
- •History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
- •History of other central nervous system disease (excluding migraine),
- •Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
- •Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
- •Current alcohol or substance abuse,
- •Lack of fluency in English which would invalidate cognitive testing,
- •Hearing or visual impairment precluding cognitive testing.
- •Exclusion criteria for Day 2 procedures:
- •Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)
研究组 & 干预措施
Personalized DBS adjustments
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
干预措施: Personalized DBS adjustments (Procedure)
结局指标
主要结局
Reaction Time
时间窗: 30-60 minutes after stimulation adjustment
Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
Verbal Fluency
时间窗: 30-60 minutes after stimulation adjustment
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Finger Tapping Speed
时间窗: 30-60 minutes after stimulation adjustment
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
次要结局
未报告次要终点
研究者
Darlene Floden
Staff Neuropsychologist
The Cleveland Clinic