Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease (SPARKL)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: ARC-IM System implantation

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.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jocelyne Bloch, MD; Phone Number: +41 79 556 29 51; Email: jocelyne.bloch@chuv.ch
• Study Contact Backup: Name: Eduardo Martin Moraud, Prof; Phone Number: +41 21 31 42 455; Email: Eduardo.Martin-Moraud@chuv.ch

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Contact: Jocelyne Dr Bloch, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Typical form of Parkinson's Disease with II-IV 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All participants; 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.

Device: ARC-IM System implantation; Implantation of a stimulation lead on the lumbar level of the spinal cord and implantation of a neurostimulator in the abdominal region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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.

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Ecole Polytechnique Fédérale de Lausanne
• Investigators: Principal Investigator: Jocelyne Bloch, MD, Centre Hospitalier Universitaire Vaudois (CHUV)

Publications and helpful links

General Publications

• Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.
• Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
• van den Brand R, Heutschi J, Barraud Q, DiGiovanna J, Bartholdi K, Huerlimann M, Friedli L, Vollenweider I, Moraud EM, Duis S, Dominici N, Micera S, Musienko P, Courtine G. Restoring voluntary control of locomotion after paralyzing spinal cord injury. Science. 2012 Jun 1;336(6085):1182-5. doi: 10.1126/science.1217416.
• Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013.
• Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.
• Capogrosso M, Wagner FB, Gandar J, Moraud EM, Wenger N, Milekovic T, Shkorbatova P, Pavlova N, Musienko P, Bezard E, Bloch J, Courtine G. Configuration of electrical spinal cord stimulation through real-time processing of gait kinematics. Nat Protoc. 2018 Sep;13(9):2031-2061. doi: 10.1038/s41596-018-0030-9.
• 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.
• Prasad S, Aguirre-Padilla DH, Poon YY, Kalsi-Ryan S, Lozano AM, Fasano A. Spinal Cord Stimulation for Very Advanced Parkinson's Disease: A 1-Year Prospective Trial. Mov Disord. 2020 Jun;35(6):1082-1083. doi: 10.1002/mds.28065. Epub 2020 Apr 20. No abstract available.
• Moraud EM, Capogrosso M, Formento E, Wenger N, DiGiovanna J, Courtine G, Micera S. Mechanisms Underlying the Neuromodulation of Spinal Circuits for Correcting Gait and Balance Deficits after Spinal Cord Injury. Neuron. 2016 Feb 17;89(4):814-28. doi: 10.1016/j.neuron.2016.01.009. Epub 2016 Feb 4.
• 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.
• 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.
• Hofstoetter US, Perret I, Bayart A, Lackner P, Binder H, Freundl B, Minassian K. Spinal motor mapping by epidural stimulation of lumbosacral posterior roots in humans. iScience. 2020 Dec 11;24(1):101930. doi: 10.1016/j.isci.2020.101930. eCollection 2021 Jan 22.
• Nishioka K, Nakajima M. Beneficial Therapeutic Effects of Spinal Cord Stimulation in Advanced Cases of Parkinson's Disease With Intractable Chronic Pain: A Case Series. Neuromodulation. 2015 Dec;18(8):751-3. doi: 10.1111/ner.12315. Epub 2015 Jun 5.
• Nicolelis MA, Fuentes R, Petersson P, Thevathasan W, Brown P. Spinal cord stimulation failed to relieve akinesia or restore locomotion in Parkinson disease. Neurology. 2010 Oct 19;75(16):1484; author reply 1484-5. doi: 10.1212/WNL.0b013e3181f46f10. No abstract available.
• Maetzler W, Nieuwhof F, Hasmann SE, Bloem BR. Emerging therapies for gait disability and balance impairment: promises and pitfalls. Mov Disord. 2013 Sep 15;28(11):1576-86. doi: 10.1002/mds.25682.
• Milekovic T, Moraud EM, Macellari N, Moerman C, Raschella F, Sun S, Perich MG, Varescon C, Demesmaeker R, Bruel A, Bole-Feysot LN, Schiavone G, Pirondini E, YunLong C, Hao L, Galvez A, Hernandez-Charpak SD, Dumont G, Ravier J, Le Goff-Mignardot CG, Mignardot JB, Carparelli G, Harte C, Hankov N, Aureli V, Watrin A, Lambert H, Borton D, Laurens J, Vollenweider I, Borgognon S, Bourre F, Goillandeau M, Ko WKD, Petit L, Li Q, Buschman R, Buse N, Yaroshinsky M, Ledoux JB, Becce F, Jimenez MC, Bally JF, Denison T, Guehl D, Ijspeert A, Capogrosso M, Squair JW, Asboth L, Starr PA, Wang DD, Lacour SP, Micera S, Qin C, Bloch J, Bezard E, Courtine G. A spinal cord neuroprosthesis for locomotor deficits due to Parkinson's disease. Nat Med. 2023 Nov;29(11):2854-2865. doi: 10.1038/s41591-023-02584-1. Epub 2023 Nov 6.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson Disease; Spinal Cord Stimulation; Epidural Spinal Stimulation
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: SPARKL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No