At a glance
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STIMO-PARKINSON: Study on Feasibility of Targeted Epidural Spinal Stimulation (TESS) to Improve Mobility in Patients With Parkinson's Disease
In Brief
A clinical study evaluating Implantation surgery for Parkinson Disease. Completed, enrolled 2 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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.
Interventions
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