Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is:
Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.
Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease (PD)
- •Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
- •Willingness to withdraw from clinical medication regimen when necessary for research visits
- •Ability to provide informed consent
排除标准
- •Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
- •History of seizures
- •Requires MRI
- •Unable to walk 100 feet without an assistive device
结局指标
主要结局
Adverse Events
时间窗: From baseline to 1 year into treatment
Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study
Swing Time Coefficient of Variation
时间窗: From baseline to 1 year into treatment
Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.
次要结局
- Percent Time Freezing(From baseline to 1 year into treatment)
- Stride Time Coefficient of Variation(From baseline to 1 year into treatment)
- Tapping Speed(From baseline to 1 year into treatment)
- Montreal Cognitive Assessment (MoCA)(From baseline to 1 year into treatment)
- General Anxiety Disorder-7 (GAD-7)(From baseline to 1 year into treatment)
- Parkinson's Disease Questionnaire-39 (PDQ-39)(From baseline to 1 year into treatment)
- Shank Angular Velocity(From baseline to 1 year into treatment)
- Tapping Rhythmicity(From baseline to 1 year into treatment)
- Percent False Positives(From baseline to 1 year into treatment)
- Distractibility(From baseline to 1 year into treatment)
- Parkinson's Disease - Cognitive Rating Scale (PD-CRS)(From baseline to 1 year into treatment)
- Judgement of Line Orientation(From baseline to 1 year into treatment)
- Neuropsychiatric Inventory (NPI)(From baseline to 1 year into treatment)
- Average + standard deviation of response time(From baseline to 1 year into treatment)
- Trails A(From baseline to 1 year into treatment)
- Trails B(From baseline to 1 year into treatment)
- MDS-UPDRS I(From baseline to 1 year into treatment)
- MDS-UPDRS IV(From baseline to 1 year into treatment)
- SAT Score(From baseline to 1 year into treatment)
- Symbol Digit Modalities (SDMT) Oral and Written(From baseline to 1 year into treatment)
- visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV)(From baseline to 1 year into treatment)
- MDS-UPDRS III Score(From baseline to 1 year into treatment)
- Percent Misses(From baseline to 1 year into treatment)
- Goal-directed focus of attention(From baseline to 1 year into treatment)
- Sustained attention(From baseline to 1 year into treatment)
- Patient Health Questionnaire-9 (PHQ-9)(From baseline to 1 year into treatment)
- MDS-UPDRS II(From baseline to 1 year into treatment)
- Caregiver Burden Assessment(From baseline to 1 year into treatment)
研究者
Helen M. Bronte-Stewart
Professor of Neurology
Stanford University