An interventional study of Implantation surgery in Parkinson Disease, sponsored by Jocelyne Bloch. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Jocelyne Bloch · Not applicable, Interventional, and Treatment
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.
The study intervention consists of 7 phases preceded by pre-screening:
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:
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 2 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Jocelyne Bloch is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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
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
Time frame: Through study completion, an average of 6 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline and during the 5-month TESS-supported rehabilitation phase
Cortical (EEG) and subcortical signals (LFP from the subthalamic nucleus)
Assess changes in brain activity patterns induced by TESS-supported physical training to get insight into the effects of TESS on brain dynamics. This will be done in the four therapy conditions for rest, for single-joint leg tasks and, if results are encouraging, for gait
Time frame: At baseline and during the 5-month TESS-supported rehabilitation phase
Quality of life questionnaire PDQ-39
Evaluate the effect of TESS-supported rehabilitation on quality of life of patients through the Parkinson's Disease Questionnaire (PDQ-39). The score ranges from 0 to 100, lower scores reflect better quality of life
Time frame: At baseline and during the 5-month TESS-supported rehabilitation phase
Quality of life questionnaire ABC-Q
Evaluate the effect of TESS-supported rehabilitation on quality of life of patients through the Activities-specific Balance Confidence Scale (ABC-Q). The score ranges from 0% to 100%, higher score reflects higher level of physical functioning
Time frame: At baseline and during the 5-month TESS-supported rehabilitation phase
Quality of life questionnaire FOG-Q
Evaluate the effect of TESS-supported rehabilitation on quality of life of patients through the Freezing of Gait Questionnaire (FOG-Q). The score ranges from 0 to 24, higher scores correspond to more severe FOG
Time frame: At baseline and during the 5-month TESS-supported rehabilitation phase
Quality of life questionnaire KPPS
Evaluate the effect of TESS-supported rehabilitation on quality of life of patients through King's Parkinson's disease pain scale. The score ranges from 0 to 168, higher scores correspond to higher pain.
Time frame: At baseline and during the 5-month TESS-supported rehabilitation phase
Therapist expectations and learnings questionnaire
Obtain information concerning the perceived efficacy of TESS-supported rehabilitation for Parkinson's patients and whether they would recommend tis new therapy for general clinical practice
Time frame: At baseline (before the patient is implanted) and at the time of study completion
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Jocelyne Bloch