STIMO-PARKINSON: Study on Feasibility of Targeted Epidural Spinal Stimulation (TESS) to Improve Mobility in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Occurence of all SAEs and AEs deemed or related to study procedure or to the study investigational system
研究概览
简要总结
The purpose of the STIMO-PARKINSON study is to evaluate the safety and preliminary efficacy of Targeted Epidural Spinal Stimulation (TESS) system to induce modulation in leg muscle recruitment in patients with advanced Parkinson's disease, and its capacity to improve key gait and balance deficits when employed in the context of a rehabilitation process of 3 to 5 months.
详细描述
The study intervention consists of 7 phases preceded by pre-screening:
- enrolment and eligibility
- baseline
- surgery
- main phase of the study
- home-use
- end of main study phase
- (optional and conditional): 3 years follow-up
At baseline, general information and Parkinson related medical history are collected. Clinical evaluations are also completed without and with current therapy, (i.e. NO(MED+DBS), and MED+DBS conditions). Finally, quality of life questionnaires are collected for the patient as well as expectations questionnaires for the physiotherapists involved in the study.
The main phase of the study consists of:
- Stimulation configuration sessions during which TESS protocols will be setup and optimized. This procedure aims to configure the spatial and temporal parameters of TESS that will recruit specific muscle groups. Specific TESS protocols will be configured for various motor tasks which will be used during the rehabilitation phase and clinical evaluations.
- TESS-supported rehabilitation sessions during which patients will undergo an in-clinic rehabilitation training regime supported by TESS.
- Evaluation sessions during which four clinical evaluation sessions will take place focusing on assessment of locomotion, balance and PD related deficits. The tests will be done when patients are:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease with III-IV Hoehn-Yahr stage, exhibiting severe gait difficulties and postural instability
- •With Medtronic DBS implant and receiving medication for Parkinson's disease
- •Aged 18 to 80 years
- •Stable medical, physical and psychological condition as considered by the Investigators in accordance with treating physician and treating neurologist.
- •Must agree to comply in good faith with all conditions of the study and to attend all required study training and visit
- •Must provide and sign the study's Informed Consent prior to any study-related procedures
排除标准
- •Severe or chronic medical disorder pre-existing PD diagnosis affecting rehabilitation
- •Active oncological disease requiring heavy treatments and frequent MRI controls
- •Having an implanted device that is active (e.g., pacemaker, implantable cardiac defibrillator) whose interference with the investigational system's neurostimulator (Activa RC) is not confirmed safe by the CE-mark of the device, or having an indication that might lead to implantation of such device
- •Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia as considered by the Investigators in accordance with treating physician and treating neurologist
- •Hematological disorders with an increased risk of hemorrhagic event during surgical interventions
- •Life expectancy of less than 12 months
- •Pregnant or breast feeding
- •Participation in another interventional study
研究组 & 干预措施
Rehabilitation supported by TESS
Patient will be asked to come to the hospital for three types of patient sessions:
- Stimulation configuration sessions: TESS protocols will be setup and optimized during this phase.
Duration: minimum 4 sessions over 2 weeks, maximum 20 sessions over a month. In addition, some sessions at a free frequency as needed during rehabilitation will be programed (maximum once a week).
- TESS-supported rehabilitation sessions: Patients will undergo an in-clinic rehabilitation training regime supported by TESS.
Duration: 24 sessions spread over minimum three months and maximum five months
- Pre- and post-rehabilitation evaluation sessions: four clinical evaluation sessions will take place focusing on assessment of locomotion, balance and PD related deficits.
干预措施: Implantation surgery (Procedure)
结局指标
主要结局
Occurence of all SAEs and AEs deemed or related to study procedure or to the study investigational system
时间窗: Through study completion, an average of 6 months
Evaluate the safety of TESS at supporting locomotor rehabilitation in patients with Parkinson's Disease
次要结局
- 10-meter walk test(At baseline and during the 5-month TESS-supported rehabilitation phase)
- Muscle Fatigue Test(At baseline and during the 5-month TESS-supported rehabilitation phase)
- Mini Balance Evaluation Systems Test (mini-BESTest)(At baseline and during the 5-month TESS-supported rehabilitation phase)
- Maximum voluntary contraction (MVC) of single joints(At baseline and during the 5-month TESS-supported rehabilitation phase)
- Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(At baseline and during the 5-month TESS-supported rehabilitation phase)
- EMG measurements of muscle recruitment in response to stimulation of increasing amplitudes for different contact configurations(At baseline and during the 5-month TESS-supported rehabilitation phase)
- 6 minute walk test(At baseline and during the 5-month TESS-supported rehabilitation phase)
- Timed up and Go test and its cognitive version, as custom-made FOG circuit(At baseline and during the 5-month TESS-supported rehabilitation phase)
- Kinematic analysis(At baseline and during the 5-month TESS-supported rehabilitation phase)
研究者
Jocelyne Bloch
Professor, Neurosurgeon
Centre Hospitalier Universitaire Vaudois