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

NCT06295614 | Recruiting DMC

• 1 other identifier: SPARKL
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Spinal Cord Stimulation; Epidural Spinal Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• 10-meter walk test

  Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)

• 6-minute walk test

  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

  Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)

• Freezing of gait circuit

  Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)

• Kinematic analysis

  Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)

Other Outcomes (5)

• Nerve conduction studies (NCS)

  Baseline assessments

• Somato-sensory evoked potential (SSEP)

  Short-term assessments (~1 month post-surgery)

• Cortical signal recording

  After surgery, until 18 weeks post-surgery

Study Arms (1)

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.

Device: ARC-IM System implantation

Interventions

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.

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (16)

• 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.

  PMID: 11877525 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.

  PMID: 15300651 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.

  PMID: 12809998 BACKGROUND

• 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.

  PMID: 35132264 BACKGROUND

• 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.

  PMID: 30382197 BACKGROUND

• 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.

  PMID: 24305828 BACKGROUND

• 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.

  PMID: 26853304 BACKGROUND

• 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.

  PMID: 30190556 BACKGROUND

• 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.

  PMID: 22654062 BACKGROUND

• 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.

  PMID: 33409476 BACKGROUND

• 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.

  PMID: 26047363 BACKGROUND

• 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.

  PMID: 20956795 BACKGROUND

• 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.

  PMID: 27862267 BACKGROUND

• 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.

  PMID: 32311155 BACKGROUND

• 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.

  PMID: 24132846 BACKGROUND

• 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.

  PMID: 37932548 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jocelyne Bloch, MD

  Centre hospitalier universitaire vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Single-site, single-arm, non-blinded, non-randomized, interventional

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 6, 2024
• Study Start: February 14, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)