Clinical trial NCT06295614: Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
Official title: Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Spinal Cord Stimulation
Epidural Spinal Stimulation
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-site, single-arm, non-blinded, non-randomized, interventional
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Typical form of Parkinson's Disease with III-V Hoehn-Yahr stage with standard therapy,
* Suffering from debilitating locomotor deficits, including gait impairments of either postural instability and/or freezing of gait, despite optimal medical management,
* 18 years of age or older,
* Able to understand and interact with the study team in French or English,
* Must use safe contraception for women of childbearing capacity,
* Must agree to comply in good faith with all conditions of the study and to attend all required study trainings and visits.
* Must provide and sign the study's Informed Consent prior to any study-related procedures.

Exclusion Criteria:

* Atypical forms of Parkinson's Disease (such as Multiple System Atrophy or Progressive Supranuclear Palsy),
* Secondary causes of gait problems independent of Parkinson's Disease,
* Inability to follow study procedures,
* Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator,
* History of major psychiatric disorders or major neurocognitive disorder as considered by the Investigators in accordance with treating physician and treating neurologist,
* Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation),
* Diseases and conditions that would increase the morbidity and mortality of the implantation surgery,
* Spinal anatomical abnormalities precluding surgery,
* History of drug or alcohol abuse in the past 5 years,
* Life expectancy of less than 12 months,
* Pregnant or breast feeding,
* Intention to get pregnant during the course of the study,
* Indication requiring frequent Magnetic Resonance Imaging (MRI),
* Experimental treatment taken in the past 5 years,
* Participation in another interventional study,
* Enrolment of the investigator, his/her family members, employees, and other dependent persons.

Primary outcomes:
measure: Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system.
timeFrame: From enrollment until end of safety follow-up phase (4 years)
Secondary outcomes:
measure: 10-meter walk test
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: 6-minute walk test
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: Timed up and Go and its cognitive version
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: Freezing of gait circuit
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: Kinematic analysis
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: Muscle analysis
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: Mini Balance Evaluation Systems Test (mini-BESTest)
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: King's Parkinson's disease Pain Scale (KPPS)
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IA & IV Part I, II & IV.
timeFrame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: Monthly, from the start of the study until the end of the home-use phase (~12 months)
measure: Activities specific Balance Confidence Questionnaire (ABC-Q)
timeFrame: Monthly, from the start of the study until the end of the home-use phase (~12 months)
measure: The Freezing of Gait Questionnaire (FOG-Q)
timeFrame: Monthly, from the start of the study until the end of the home-use phase (~12 months)
measure: Home-use kinematic monitoring
timeFrame: Weekly, from the start of the study until the end of the home-use phase (~12 months)
measure: Daily falls tracking
timeFrame: Weekly, from the start of the study until the end of the home-use phase (~12 months)
measure: Satisfaction questionnaire
timeFrame: Monthly, from the Short-Term assessments (~1 month post-surgery) until the end of the home-use phase (~12 months)
measure: User Evaluation of Satisfaction with technology (QUEST 2.0)
timeFrame: Follow-Up assessments (~4 & 11 months post-surgery)
measure: System Usability Scale (SUS)
timeFrame: Follow-Up assessments (~4 & 11 months post-surgery)
Other outcomes:
measure: Nerve conduction studies (NCS)
timeFrame: Baseline assessments
measure: Somato-sensory evoked potential (SSEP)
timeFrame: Short-term assessments (~1 month post-surgery)
measure: Cortical signal recording
timeFrame: After surgery, until 18 weeks post-surgery
measure: Kinematic analysis in different therapeutic conditions
timeFrame: After surgery, until 18 weeks post-surgery
measure: Muscle analysis in different therapeutic conditions
timeFrame: After surgery, until 18 weeks post-surgery
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
state: Vaud
Study officials:
affiliation: Centre hospitalier universitaire vaudois (CHUV)
name: Jocelyne Bloch, MD
role: PRINCIPAL_INVESTIGATOR
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