Adaptive Deep Brain Stimulation to Improve Freezing of Gait in Parkinson's Disease Using Percept RC
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Freezing of gait
研究概览
简要总结
The goal of this clinical trial is to learn if adaptive deep brain stimulation (DBS) can decrease or prevent freezing of gait in participants with Parkinson's disease.
详细描述
The main questions it aims to answer are:
- Does adaptive DBS lead to fewer freezing of gait episodes for participants compared to their clinical continuous DBS settings?
- Does adaptive DBS change other parts of participants' walking, like step length, step time, or step symmetry?
Investigators will compare personalized adaptive DBS settings for each participant with their continuous DBS settings to see if adaptive DBS works better to treat gait symptoms, including freezing of gait.
Participants will have DBS insertion surgery as part of their standard medical care. Along with the DBS system, they will also have permanent sensors placed between their skull and scalp to detect brain activity related to movement. After, participants will:
- Measure their walking using at-home monitoring devices (worn on the hip or ankles) while on their clinical continuous DBS settings.
- Visit the lab for check-ins and testing of adaptive DBS settings.
- Try different adaptive DBS settings at home, while wearing at-home monitoring devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent for the study
- •Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
- •Patient has requested surgical intervention with deep brain stimulation for their disorder
- •No magnetic resonance (MR) abnormalities that suggest an alternative diagnosis or contraindicate surgery
- •Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA)),
- •Signed informed consent
- •Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
- •Diagnosis of idiopathic PD with duration of motor symptoms for 3 years or greater
- •Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist.
- •UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia.
- •OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management
- •Patients with gait impairments including freezing of gait off medication.
- •Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel.
排除标准
- •Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
- •Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
- •Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
- •Significant untreated depression (BDI-II score >20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
- •Any personality or mood symptoms that study personnel believe will interfere with study requirements.
- •Subjects who require Electroconvulsive therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS) or diathermy
- •Implanted stimulation systems such as cochlear implant, pacemaker, defibrillator, or neurostimulator
- •Previous cranial surgery
- •Drug or alcohol abuse
- •Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests.
- •Known allergies to the implantable device components including titanium, polyurethane, silicone, and nylon.
研究组 & 干预措施
Open-loop deep brain stimulation
Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving open-loop deep brain stimulation.
干预措施: Percept RC (Device)
Adaptive deep brain stimulation (ramp-up)
Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving increased stimulation in-response to gait-behavior biomarker.
干预措施: Percept RC (Device)
Adaptive deep brain stimulation (ramp-down)
Participants with Parkinson's disease implanted with Percept RC and brain lead implanted in the pallidal/striatal region receiving decreased stimulation in-response to gait-behavior biomarker.
干预措施: Percept RC (Device)
结局指标
主要结局
Freezing of gait
时间窗: Baseline and 2 years
Freezing of gait episodes will be detected using validated home wearable devices along with participant self-reporting.
次要结局
- Change in Stride Length(Baseline and 2 years)
- Change in Arm Swing Amplitude(Baseline and 2 years)
- Change in Gait Symmetry(Baseline and 2 years)
- Change in MDS-UPDRS III scores(Baseline and 2 years)
- Change in Gait(Baseline and 2 years)
- Change in Balance(Baseline and 2 years)
- Change in Stride Time(Baseline and 2 years)
- Change in Gait Variance(Baseline and 2 years)
- Change in Total Electrical Energy Delivered (TEED)(Baseline and 2 years)
研究者
Doris Wang, MD, PhD
Associate Professor, Neurological Surgery
University of California, San Francisco