Adaptive/Closed Loop vs. Continuous/Open Loop Deep Brain Stimulation of Subthalamic Nucleus: a Two-Phase, Cross-Over, Double-Blind Trial in Patients With 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
- Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)
研究概览
简要总结
Parkinsonian symptoms, such as freezing of gait (FOG) or hypophonia, play a significant role in reducing quality of life for Parkinson disease (PD) patients, and are poorly responsive or can worsen with deep brain stimulation (DBS). Repeated adjustments of stimulation parameters may be beneficial however, continuous DBS (cDBS) does not adapt to the patients' rapidly fluctuating clinical status and does not take into account reliable and consistent state-trait biomarkers. These biomarkers can be recorded by the electrode itself as local field potentials (LFP). These LFPs can be used to guide stimulation output by means of a 'closed loop' or 'adaptive' DBS (aDBS).
This is a pilot, two-phase, double-blinded, cross-over study of chronic Adaptive vs. Continuous STN DBS in patients with PD by using a novel implantable DBS system that can automatically adjust stimulation parameters based on the patient's clinical condition. The study will test the hypothesis that aDBS stimulation will treat motor fluctuations similarly to continuous stimulation but it will be superior to the latter in the treatment of speech, gait impairment and falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD treated with bilateral STN DBS using Medtronic lead
- •Able to provide informed consent and comply with study protocol
- •Need to replace the implantable pulse generator (IPG) due to battery end of life
- •Presence of disabling gait and/or balance and/or speech issues, as clinically judged by the PI and the patient
- •Evidence that these disabling gait and/or balance and/or speech issues are worsened by DBS, i.e. they improve after turning DBS off.
- •Use of contact 1 and/or 2 on one hemisphere and/or 9 and/or 10 on the other one
- •Good LFP signal (assessable only after IPG replacement with Percept) in at least one hemisphere
排除标准
- •Previous DBS surgery without Medtronic products
- •Potential use of any therapeutic stimulation configuration (such as bipolar) during the study which will prevent the use of aDBS
- •Presence of any other disorders potentially impacting the outcome measures (e.g. orthopaedic issues)
- •Medically unstable
- •Severe non-motor problems, such as depression, dementia, etc.
结局指标
主要结局
Change in Quality of Life (QoL) using Parkinson's Disease Questionnaire (PDQ39)
时间窗: Baseline, 5 months after IPG change, 8 months after battery change
Parkinson's Disease Questionnaire (PDQ39): 8 dimensions, 5-point ordinal scoring system, each dimension total score range from 0 to 100. Lower scores reflect better QoL.
Change in Activities of Daily Living using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II
时间窗: Baseline, 5 months after IPG change, 8 months after battery change
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) II: Motor Aspects of Experiences of Daily Living (M-EDL), range 0-52. Lower scores reflect better motor experience.
Change in Speech Quality using the Praat software (Phonetic Sciences)
时间窗: Baseline, 5 months after IPG change, 8 months after battery change
Phonetic speech analysis (off and on medication) using the Praat software (Phonetic Sciences, Amsterdam, The Netherlands). Increased phonation reflects better speech quality.
Change in Gait using the Zeno Walkway by Protokinetics
时间窗: Baseline, 5 months after IPG change, 8 months after battery change
Gait analysis (off and on medication) using the Zeno Walkway by Protokinetics.
次要结局
- Change in Motor Outcomes (adaptive DBS vs continuous DBS arms) using Unified Parkinson's Disease Rating Scale part III (motor examination)(Baseline, 2-5 months after IPG change, 8 months after battery change)
研究者
Alfonso Fasano
Professor - University of Toronto
University of Toronto