Recording and Modulation of Brain Activity Through Chronically Implanted Stimulation Electrodes in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Changes in brain dynamics induced by DBS parameters
研究概览
简要总结
For decades, deep brain stimulation (DBS) therapies have been employed very successfully to alleviate segmental motor symptoms (tremor, brady-kinesia or rigidity) in patients with Parkinson's disease (PD). Unfortunately these therapies often fail to alleviate, or can even aggravate, axial deficits such gait and balance disorders. This is presumably due to the divergence in the dynamics of the circuits that control leg function, which are not well addressed with commonly employed stimulation protocols.
To date, patients still endure life-long debilitating gait difficulties that severely affect their everyday mobility, independence and quality of life.
In recent years, a handful of studies have proposed new paradigms, for instance using different stimulation parameters that are thought to be better suited for targeting the circuits that control lower limb function. Although promising, the resulting observations have been far from conclusive. As a result, the relevant approaches for therapeutic intervention remain unclear, and the underlying mechanisms largely unknown.
Advances on the use of implantable neuromodulation devices and of tech-nologies for monitoring whole-body movement currently allow to study locomotor deficits in ecological environments, enabling the recording and modulation of motor and neural signals while patients perform activities of daily living, chronically, wirelessly and in real time.
详细描述
This project seeks to leverage the latest technological innovations for monitoring and modulating motor and neural states chronically, in order to comprehensively characterize gait deficits in PD, and to clarify the improvements ushered in by varying DBS parameters.
The resulting observations will establish a rigorous understanding that will open new avenues for the design of evidence-based, clinically-relevant DBS strategies for locomotor deficits.
Advances on the use of neural implants for electrical neuromodulation of deep brain structures are opening the unique opportunity to probing the function of dysfunctional circuits in patients suffering from a variety of neurological disorders.
To date, acute experiments using deep brain stimulation (DBS) implants, either in intra-operative setups or shortly after surgery during so-called "externalization" phases, have widened our understan-ding of the neural signatures that underlie various motor and non-motor symptoms, and helped optimi-ze therapeutical parameters to better address such impairments.
For instance, DBS therapies in Parkinson's disease (PD) have been refined over the past decades based on experiments that synergistically (i) explored and uncovered readouts of movement perfor-mance in response to changing stimulation parameters, (ii) identified the underlying neural biomar-kers from recordings of local field potentials, and even (iii) tested closed-loop strategies able to adapt in real-time to ongoing patient-specific requirements.
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
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
- •Age: 18 years old or more
- •Informed Consent as documented by signature
- •Diagnosed with Parkinson's disease, and being treated with deep brain stimulation therapies.
- •Exhibiting severe locomotor deficits
- •Agree to comply in good faith with all conditions of the recordings.
排除标准
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another investigational study in the preceding 30 days
- •Previous enrolment into the current study
结局指标
主要结局
Changes in brain dynamics induced by DBS parameters
时间窗: Neural recordings will be performed prior to each UPDRS recording (2 minute recording every 15 minutes)
Changes in neural signatures (EEG at rest) will be measured to extract temporal changes and their correlation with motor scores for each condition
Changes in gait quality induced by DBS parameters
时间窗: Quality of gait patterns is performed during one walking recording, every 15 minutes up to 60 minutes for every condition.
Quality in gait will compare the walking patterns of each patient with respect to healthy subjects : for that, multi-factorial analysis will be applied on recordings of kinematics (3D positions of body-joints recorded using a motion capture system). These multi-faceted signals are discretised per gait cycle, zscored, and their correlations extracted through Principal Component Analysis, which allows to identify key patterns being modulated with the therapy.
Changes in global motor scores induced by DBS parameters
时间窗: UPDRS scores will be measured by an expert clinician every 15 minutes after each gait recording, up to 60 minutes per condition
Unified Parkinson's Disease Rating Scores (UPDRS III)
Changes in gait performance induced by DBS parameters
时间窗: Measurement of performance is performed every 15 minutes up to 60 minutes for every condition.
Improvements in performance will be evaluated using the results of the 10 meter test
次要结局
未报告次要终点
研究者
Jocelyne Bloch
Neurosurgeon, Professor in Neurosurgery
Centre Hospitalier Universitaire Vaudois