NCT04956770

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Jocelyne Bloch · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
PROCEDURE	Implantation surgery	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

Timeline

• Start date: 2021-06-14
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2021-07-09
• Last updated: 2023-09-06

Locations

1 site across 1 country: Switzerland