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The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease.
The progression of Parkinson's Disease (PD) is often marked by the development of severe locomotor deficits, including gait impairments, which significantly affect patients' independence and are not effectively addressed by current treatments. The STIMO-PARKINSON (NCT04956770) clinical trial has shown promising results with epidural electrical stimulation (EES) in significantly reducing these locomotor deficits in Parkinson's Disease patients.
Building on these findings, the SPARKL clinical study aims to further this research. The SPARKL study aims to enroll six individuals with advanced Parkinson's Disease to assess the safety and efficacy of the novel ARC-IM Therapy. This new therapy has been designed to overcome previous technological limitations and facilitate its home-use.
This study will take place at the Lausanne University Hospital (CHUV, Switzerland). The total duration of the study is 4 years per participant. The study intervention consists of several phases preceded by pre-screening. The first year involves an intensive participation, consisting of the following phases: enrolment and baseline, surgical implantation of the stimulation device, a main study phase that includes stimulation configuration sessions and both in-clinic and at-home rehabilitation, and finally the home-use phase. This will be succeeded by 3 years of safety follow-up, during which the participant can use the stimulation device in their daily life, subject to investigator approval.
Throughout the study, the investigators will conduct assessments at various stages of each participant's journey in the study. These assessments will be used to assess the preliminary safety and efficacy of the ARC-IM therapy at alleviating locomotor deficits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants enrolled in the study will receive the same intervention. The first year of the study consists of the following phases: enrolment, baseline assessments, surgical implantation of the ARC-IM stimulation device, configuration sessions for stimulation, in-clinic and at-home rehabilitation, and a home-use phase. It is followed by 3 years of safety follow-up. Assessments will be planned throughout the course of the study and at baseline, the end of the optimization phase, the end of the rehabilitation phase, and after 12 months post-surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-IM System implantation | Device | Implantation of a stimulation lead on the lumbar level of the spinal cord and implantation of a neurostimulator in the abdominal region. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system. | Assess the safety of the ARC-IM Therapy at alleviating locomotor deficits in people with Parkinson's Disease. | From enrollment until end of safety follow-up phase (4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 10-meter walk test | To assess gait speed. Measurement tool: time (s) | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| 6-minute walk test |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve conduction studies (NCS) | To assess status of peripheral nervous system. Measurement tool: electrical activity in the nerve (mV) | Baseline assessments |
| Somato-sensory evoked potential (SSEP) | To assess the transmission of electrical activity from a touch stimulation. Measurement tool: electrical activity in the nerve (mV) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jocelyne Bloch, MD | Contact | +41 79 556 29 51 | jocelyne.bloch@chuv.ch | |
| Eduardo Martin Moraud, Prof | Contact | +41 21 31 42 455 | Eduardo.Martin-Moraud@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jocelyne Bloch, MD | Centre hospitalier universitaire vaudois (CHUV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11877525 | Background | Yakovenko S, Mushahwar V, VanderHorst V, Holstege G, Prochazka A. Spatiotemporal activation of lumbosacral motoneurons in the locomotor step cycle. J Neurophysiol. 2002 Mar;87(3):1542-53. doi: 10.1152/jn.00479.2001. | |
| 15300651 | Background | Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. doi: 10.1002/mds.20115. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Single-site, single-arm, non-blinded, non-randomized, interventional
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To assess endurance. Measurement tool: distance (m)
| Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| Timed up and Go and its cognitive version | To assess freezing of gait prevalence. Measurement tool: time (s) | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| Freezing of gait circuit | To assess freezing of gait prevalence. Measurement tool: time (s) | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| Kinematic analysis | Gait circuit to assess gait kinematic. Measurement tool: changes in position and orientation of the body through sensors (mm) | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| Muscle analysis | Gait circuit to assess muscle activity. Measurement tool: muscle activity through sensors (mV) | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| Mini Balance Evaluation Systems Test (mini-BESTest) | 4-item test to assess balance. Measurement tool: total score | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | 19 item-test to assess the course of Parkinson's Disease. Measurement tool: total score from 0 up to 132. Low score means a better outcome. | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| King's Parkinson's disease Pain Scale (KPPS) | 7-item questionnaire to assess daily life performance. Measurement tool: total score 0 up to 168. Low score means a better outcome. | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV. | 3-part questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 128. Low score means a better outcome. | Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery) |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | 39-item questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 100. Low score means a better outcome. | Monthly, from the start of the study until the end of the home-use phase (~12 months) |
| Activities specific Balance Confidence Questionnaire (ABC-Q) | 16-item questionnaire to assess daily life performance. Measurement tool: total score from 0 up to 100. High score means a better outcome. | Monthly, from the start of the study until the end of the home-use phase (~12 months) |
| The Freezing of Gait Questionnaire (FOG-Q) | 6-item questionnaire to assess daily life performance. Measurement tool: total score 0 up to 24. High score means a better outcome. | Monthly, from the start of the study until the end of the home-use phase (~12 months) |
| Home-use kinematic monitoring | To assess gait pattern in ecological environment. Measurement tool: changes in position and orientation of the feet through sensors placed on shoes (mm) | Weekly, from the start of the study until the end of the home-use phase (~12 months) |
| Daily falls tracking | To assess daily falls. Measurement tool: number of falls | Weekly, from the start of the study until the end of the home-use phase (~12 months) |
| Satisfaction questionnaire | 16-item questionnaire to collect feedback from the therapy. Measurement tool: total score from 0 up to 100. | Monthly, from the Short-Term assessments (~1 month post-surgery) until the end of the home-use phase (~12 months) |
| User Evaluation of Satisfaction with technology (QUEST 2.0) | 12-item questionnaire to assess usability of the therapy. Measurement tool: total score from 12 up to 60. Low score means a better outcome. | Follow-Up assessments (~4 & 11 months post-surgery) |
| System Usability Scale (SUS) | Questionnaire to assess usability of the therapy. Measurement tool: total score from 0 to 100. High score means a better outcome. | Follow-Up assessments (~4 & 11 months post-surgery) |
| Montreal Cognitive assessment (MoCA) | 30-item test to assess global cognitive function across multiple domains including memory, attention, language, and executive function. Measurement tool: total score from 0 up to 30. High score means a better outcome. | Baseline (before surgery), Follow-Up assessments (~4 & 11 months post-surgery) and safety follow-up visits. |
| Patient Global Impression of Change (PGI-C) | 7-point single-item scale assessing the patient's self-reported overall change since the start of treatment. Measurement tool: score from 1 to 7. Low score means a better outcome. | Short-Term assessments (~1 month post-surgery), Follow-Up assessments (~4 & 11 months post-surgery), and safety follow-up visits. |
| Semi-structured interview | Investigator-conducted interview assessing the participant's subjective well-being and the general effect of the therapy on daily life. Measurement tool: qualitative data. | Short-Term assessments (~1 month post-surgery), Follow-Up assessments (~4 & 11 months post-surgery), and safety follow-up visits. |
| Short-term assessments (~1 month post-surgery) |
| Cortical signal recording | To assess changes in brain activity patterns. Measurement tool: electrical activity in the brain (mV) | After surgery, until 18 weeks post-surgery |
| Kinematic analysis in different therapeutic conditions | Gait circuit to assess gait kinematic changes. Measurement tool: changes in position and orientation of the body through sensors (mm) | After surgery, until 18 weeks post-surgery |
| Muscle analysis in different therapeutic conditions | Gait circuit to assess muscle activity change. Measurement tool: muscle activity through sensors (mV) | After surgery, until 18 weeks post-surgery |
| 12809998 | Background | Schaafsma JD, Giladi N, Balash Y, Bartels AL, Gurevich T, Hausdorff JM. Gait dynamics in Parkinson's disease: relationship to Parkinsonian features, falls and response to levodopa. J Neurol Sci. 2003 Aug 15;212(1-2):47-53. doi: 10.1016/s0022-510x(03)00104-7. |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |