Study on Preliminary Safety and Efficacy of Adaptive DBS Aligned to Locomotor States to Improve Locomotor Functions in Parkinson's Patients
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
- 1
- 主要终点
- Adverse events
研究概览
简要总结
At present, there is no cure for Parkinson's disease. The standard treatment involves taking dopaminergic drugs. When drugs lose their effectiveness, they can be supplemented by Deep Brain Stimulation (DBS) therapy. Medication and deep brain stimulation are effective for motor problems such as tremors, slowness of movement, and muscle stiffness. However, there is no effective treatment for walking and balance problems that occur during the course of the disease.
DBS neurostimulators not only stimulate, but also record brain activity in the region in which the electrodes are implanted. This brain activity changes over time, depending on the individual's general state (i.e., medication, eating), movements (sitting, standing or walking) and motor problems (i.e., problems of gait initiation and termination, balance problems and freezing of gait).
Adaptive deep brain stimulation (aDBS) makes it possible to change the stimulation according to brain activity, and thus to these different states. This method involves using the usual Medtronic Percept neurostimulator with its adaptive therapy active. Additional investigational features for adaptive therapy are available within the study.
In this study, we want to evaluate whether adaptive deep brain stimulation is safe and effective in improving walking problems in people with Parkinson's disease.
详细描述
The hypotheses of the current study are that:
HYPOTHESIS 1: Adaptive DBS, aligned in time to the occurrence of locomotor states, facilitates gait initiation, termination, turning, symmetry and adaptations to obstacles by titrating the delivery of stimulation to the dynamics of gait.
HYPOTHESIS 2: Enforcing that biomarkers of FoG never exceed an abnormally-high value prevents the occurrence of freezing of gait.
The resulting observations will establish a rigorous understanding of motor state-dependent DBS modulations that will open new avenues for the design of evidence-based DBS strategies for locomotor deficits.
The study is divided into 3 different phases, which will take place on 3 different days at CHUV, and will be spread over a maximum of 5 weeks:
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
- •Diagnosed with typical or atypical forms of Parkinson's disease; Suffering from gait or balance disorders;
- •Implanted with a full Medtronic Percept suite (neurostimulator Percept PC Model B35200 or Percept RC Model B35300; with bilateral leads (Medtronic Legacy leads (Models 3387 and 3389) or Medtronic SenSightTM Directional Lead (models B33015 and B33005)) and lead extensions (Medtronic extensions (Model 37085 and 37086) or SenSightTM extension (model B34000)), or Medtronic SenSightTM Connector Plug (Model B31061));
- •Exhibit modulations in at least one frequency band of the LFP that are related to locomotor states or gait deficits.
- •Aged 18 years-old or more;
- •Must provide and sign the study's Informed Consent prior to any study-related procedures;
- •Able to understand and interact with the study team in French;
- •Agree to comply in good faith with all conditions of the recordings, and to attend all required study procedures
排除标准
- •Exclusive use of interleaved DBS programs that are incompatible with aDBS;
- •High impedances or artefacts in neural signals that obstruct the detection of motor-related biomarkers for adaptive DBS;
- •Changes in DBS amplitudes (increase/decrease) not well tolerated;
- •Secondary causes of gait problems independent of PD;
- •Inability to follow the procedures of the study independently;
- •History of major psychiatric disorders or major neurocognitive disorders, as considered by the investigators in according with treating physicians;
- •Major changes in PD treatments planned within the course of the study;
- •History of drug or alcohol abuse in the past 5 years;
- •Pregnancy;
- •Participation in another investigational study in the preceding 30 days or during the study
研究组 & 干预措施
Adaptive DBS
干预措施: Adaptive DBS (Device)
结局指标
主要结局
Adverse events
时间窗: Through study completion, a maximum of 5 weeks
Occurrence of adverse events and serious adverse events that are deemed related or possibly related to the study procedures, or the use of the investigational system during the duration of the study
次要结局
- Gait performance(At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.)
- Freezing of Gait occurances(At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.)
- Global Parkinsonian State(At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.)
- Changes in neural patterns(At Phase 1 (Day1) and Phase 2 (2 to 3 days within a maximum of 5 weeks from Day1) of the study.)
- Sustained efficacy of adaptive DBS during activities of daily life - kinematics parameters(At Phase 2, during the last day of the study (2nd or 3rd day of Phase 2 within a maximum of 5 weeks from Day1 of Phase 1).)
- Sustained efficacy of adaptive DBS during activities of daily life - questionnaire(At Phase 2, during the last day of the study (2nd or 3rd day of Phase 2 within a maximum of 5 weeks from Day1 of Phase 1).)
研究者
Jocelyne Bloch
Professor
Centre Hospitalier Universitaire Vaudois