Study on Feasibility of Targeted Epidural Spinal Stimulation (TESS) to Improve Mobility in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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: (i) in NO(MED+DBS) condition (without any therapy, i.e. without medication and DBS OFF) (ii) in MED+DBS condition (the patient's standard therapeutical condition, i.e. usual medication dose and DBS ON) (iii) in TESS+MED condition (usual medication dose, TESS ON, DBS OFF) (iv) in TESS+MED+DBS condition (usual medication dose, TESS ON, DBS ON) Participants are allowed to use the investigational system independently if deemed safe and beneficial as assessed by the Principal Investigator (Home-Use Phase). One year after patient enrolment, the patient will come for follow up visits where he will again perform an evaluation session for each therapy condition as described above, to evaluate the long-term evolution. If the therapy has been safe and beneficial, they can extend their study participation by entering the Follow-Up period of 3 years.

Official Title
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STIMO-PARKINSON: Study on Feasibility of Targeted Epidural Spinal Stimulation (TESS) to Improve Mobility in Patients With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Implantation surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single center, non-randomized, interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation supported by TESS<br>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. | Procedure: Implantation surgery<br>* The intervention involves the implantation of: a neurostimulator: the Activa® RC from Medtronic a stimulation electrode paddle array: the Specify™ SureScan® 5-6-5 from Medtronic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of all SAEs and AEs deemed or related to study procedure or to the study investigational system | Evaluate the safety of TESS at supporting locomotor rehabilitation in patients with Parkinson's Disease | Through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EMG measurements of muscle recruitment in response to stimulation of increasing amplitudes for different contact configurations | Assess the preliminary efficacy outcome of TESS to induce modulations in muscle recruitment selectivity by measuring the EMG response to iterative stimulation pulses of increasing amplitude for different contact configurations | At baseline and during the 5-month TESS-supported rehabilitation phase | 
| Maximum voluntary contraction (MVC) of single joints | Assess the preliminary efficacy of TESS on motor performance through changes in single joint leg muscle strength and fatigue | At baseline and during the 5-month TESS-supported rehabilitation phase | 
| Muscle Fatigue Test | Measure the time the patient can maintain a certain percentage of his MVC measured in the MED+DBS condition. This is used to assess the preliminary efficacy of TESS on motor performance through changes in single joint leg muscle strength and fatigue | At baseline and during the 5-month TESS-supported rehabilitation phase | 
| 10-meter walk test | Assess the preliminary efficacy of TESS on motor performance through changes in gait speed and endurance | At baseline and during the 5-month TESS-supported rehabilitation phase | 
| 6 minute walk test | Assess the preliminary efficacy of TESS on motor performance through changes in gait speed and endurance | 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 | Assess the preliminary efficacy of TESS for alleviating deficits specific to PD related to freezing of gait (FOG) | At baseline and during the 5-month TESS-supported rehabilitation phase | 
| Kinematic analysis | Assess the preliminary efficacy of TESS for alleviating deficits specific to PD related to posture using motion sensors acquisition system | At baseline and during the 5-month TESS-supported rehabilitation phase | 
| Mini Balance Evaluation Systems Test (mini-BESTest) | Assess the preliminary efficacy of TESS for alleviating deficits specific to PD related to balance | At baseline and during the 5-month TESS-supported rehabilitation phase | 
| Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Assess the preliminary efficacy of TESS for alleviating deficits specific to PD related to motor and non-motor functions. Higher scores indicate greater impact of Parkinson's disease symptoms | At baseline and during the 5-month TESS-supported rehabilitation phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DBS, Spinal Cord Stimulation System