Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11)
研究概览
简要总结
Deep brain stimulation (DBS) in the dorsal region of the subthalamic nucleus (STN) is very effective for reducing motor symptoms of Parkinson's disease (PD). Modeling studies suggest that this therapy may result in current spread into the ventral STN, causing altered cognitive processes. As a result, current stimulation parameters often lead to worsening in verbal fluency, executive function, and, particularly, cognitive control. There is evidence suggesting that low frequency oscillatory activity occurs across brain circuits important in integrating information for cognition. Preclinical studies and human recording studies indicate these low frequency theta oscillations drive cognitive control during cognitive tasks. Thus, the purpose of this study is to determine the safety, tolerability, and efficacy of low frequency stimulation (LFS) of the ventral STN alongside standard high frequency stimulation (HFS) of the dorsal STN in patients with PD.
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
盲法说明
Open-label
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
- •Individuals who are 18 years and older
- •Individuals with idiopathic Parkinson's Disease who previously underwent implantation with the Boston Scientific VerciseTM DBS system
- •Individuals who have been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months
- •Individuals diagnosed with advanced PD who had bilateral dorsal subthalamic nucleus DBS surgery, as standard of care for motor improvement, with distal contacts of the electrodes implanted into the ventral STN
排除标准
- •Individuals unable to provide consent and/or lack capacity to consent
- •Individuals diagnosed with any cognitive or physical impairments that would limit their ability to participate in the cognitive testing
- •Individuals who score below 15 on the Montreal Cognitive Assessment Test-Blind
- •Individuals who score above 20 on the Center for Epidemiologic Studies Depression Scale
- •Pregnant women (note: pregnant women are not candidates for DBS surgery), and prisoners
- •Non-English speaking individuals. Cognitive tasks will only be conducted in English.
研究组 & 干预措施
Sustained Dual Frequency, Dual Region, Stimulation
干预措施: Deep brain stimulation (Device)
结局指标
主要结局
Mean Change from Baseline in Impulsiveness Scores on the Barratt Impulsiveness Scale (BIS-11)
时间窗: Baseline, Week 2, Week 6, Month 3, and Month 6
The score of the BIS-11 will be evaluated across sessions and elevated scores indicate greater impulsivity and risk-taking behavior. The scale involves 30 questions with values from 1-4. Overall scores range from 30-120.
Mean Change from Baseline in Neuropsychiatric Inventory (NPI)
时间窗: Baseline, Week 2, Week 6, Month 3, and Month 6
The NPI assesses frequency, change in severity, and distress over 12 neuropsychiatric domains as evaluated by the caregiver. We will look for a significant score reduction in any domain of the NPI.
Mean Change from Baseline in Cognitive Performance Scores on the Montreal Cognitive Assessment - Blind (MoCA)
时间窗: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5
This will be collected via telephone calls. The MoCA-Blind has been validated for telephone administration. We will re-evaluate MoCA-Blind scores during telephone monitoring to assess any changes to cognitive ability. A total score of less than 15 out of a possible 22 indicates greater than mild cognitive impairment.
Mean Change from Baseline in Depression Scores on the Center for Epidemiologic Studies Depression Scale (CES-D)
时间窗: Baseline, Week 2, Week 6, Month 3, and Month 6
The score of the CES-D will be compared across sessions and a score that rises above 20 (out of 60) will be considered positive for the development of depression.
Mean Change from Baseline in Movement Scores on Part III of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
时间窗: Baseline, Week 2, Week 6, Month 3, and Month 6
Part III of the MDS-UPDRS consists of 18 areas of motor assessments to assess severity of symptoms. Each score is rated in terms of severity from 0-4, with higher scores indicating higher severity of symptoms. A composite score will be evaluated for changes from baseline.
Mean Change from Baseline in Depression Scores on the CES-D Short Version (CES-D-R10)
时间窗: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5
This will be collected via telephone calls. Patients will be given an unmarked form with questions and will be able to follow along the telephone conversation and answer each question (0-4 severity rating scale) for 10 questions focused on patient affect. A total score greater than 10 (out of 30) indicates the development of depression symptoms.
Mean Change from Baseline in Motor and Non-Motor Aspects of Daily Living Scores on Parts I and II of the MDS-UPDRS
时间窗: Baseline, Hour 24, Week 1, Month 1, Month 2, Month 4, and Month 5
This will be collected via telephone calls. Patients will be asked questions relating to motor and non-motor aspects of daily living and to rate the severity of their symptoms on a scale from 0-4, with higher scores indicating higher severity of symptoms. We will assess for changes in the composite score from baseline.
次要结局
- Mean Change from Baseline in Inter-Temporal Choice Scores on a Temporal Discounting Task(Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6)
- Mean Change from Baseline in Decision-Making Scores on Probabilistic Gambling Task(Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6)
- Mean Change from Baseline in Verbal Fluency Scores on Word Generation Task(Baseline, Minute 30, Week 2, Week 6, Month 3, and Month 6)