Parkinson DiseaseSPARKLNCT06295614
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
A study testing ARC-IM System implantation in people with Parkinson Disease, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ARC-IM System implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Feb 2024to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Jocelyne Dr Bloch, Prof. Dr.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- ARC-IM System implantation
- Keywords
- Parkinson Disease, Spinal Cord Stimulation, Epidural Spinal Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-IM System implantationDevice
Implantation of a stimulation lead on the lumbar level of the spinal cord and implantation of a neurostimulator in the abdominal region.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ARC-IM System implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until end of safety follow-up phase (4 years)
Secondary outcomes (21)
10-meter walk test
To assess gait speed. Measurement tool: time (s)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Short-Term assessments (~1 month post-surgery), Follow-Up assessments (~4 & 11 months post-surgery), and safety follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start14 Feb 2024
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-site, single-arm, non-blinded, non-randomized, interventional
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Jocelyne Bloch, MD, Principal investigator, Centre hospitalier universitaire vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295614
- Sponsor's protocol ID
- SPARKL
- Acronym
- SPARKL
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11877525Bloem 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.
PubMed 15300651Schaafsma 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.
PubMed 12809998Rowald 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.
PubMed 35132264Wagner 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.
PubMed 30382197Capogrosso 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.
PubMed 24305828Moraud 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.
PubMed 26853304Capogrosso 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.
PubMed 30190556van 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.
PubMed 22654062Hofstoetter 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.
PubMed 33409476Nishioka 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.
PubMed 26047363Nicolelis 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.
PubMed 20956795Pinto 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.
PubMed 27862267Prasad 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.
PubMed 32311155Maetzler 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.
PubMed 24132846
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06295614
- Acronym / sponsor ID
- SPARKL / SPARKL
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Spinal Cord Stimulation, Epidural Spinal Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-site, single-arm, non-blinded, non-randomized, interventional
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: ARC-IM System implantationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC-IM System implantationImplantation of a stimulation lead on the lumbar level of the spinal cord and implantation of a neurostimulator in the abdominal region. | Device | All participants |
Primary outcome
Occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedures or to the investigational system.
Time frame: From enrollment until end of safety follow-up phase (4 years)
Assess the safety of the ARC-IM Therapy at alleviating locomotor deficits in people with Parkinson's Disease.
21 secondary outcomes
10-meter walk test
Time frame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
6-minute walk test
Time frame: 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
Time frame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
Freezing of gait circuit
Time frame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
Kinematic analysis
Time frame: Baseline (before surgery), Short-Term assessments (~1 month post-surgery) and Follow-Up assessments (~4 & 11 months post-surgery)
Muscle analysis
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: Monthly, from the start of the study until the end of the home-use phase (~12 months)
Activities specific Balance Confidence Questionnaire (ABC-Q)
Time frame: Monthly, from the start of the study until the end of the home-use phase (~12 months)
The Freezing of Gait Questionnaire (FOG-Q)
Time frame: Monthly, from the start of the study until the end of the home-use phase (~12 months)
Home-use kinematic monitoring
Time frame: Weekly, from the start of the study until the end of the home-use phase (~12 months)
Daily falls tracking
Time frame: Weekly, from the start of the study until the end of the home-use phase (~12 months)
Satisfaction questionnaire
Time frame: 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)
Time frame: Follow-Up assessments (~4 & 11 months post-surgery)
System Usability Scale (SUS)
Time frame: Follow-Up assessments (~4 & 11 months post-surgery)
Montreal Cognitive assessment (MoCA)
Time frame: Baseline (before surgery), Follow-Up assessments (~4 & 11 months post-surgery) and safety follow-up visits.
Patient Global Impression of Change (PGI-C)
Time frame: Short-Term assessments (~1 month post-surgery), Follow-Up assessments (~4 & 11 months post-surgery), and safety follow-up visits.
Semi-structured interview
Time frame: Short-Term assessments (~1 month post-surgery), Follow-Up assessments (~4 & 11 months post-surgery), and safety follow-up visits.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 11877525Yakovenko 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.
- Background: PubMed 15300651Bloem 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.
- Background: PubMed 12809998Schaafsma 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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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jocelyne Bloch, MD principal investigator
Centre hospitalier universitaire vaudois (CHUV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARC-IM System implantation in people with Parkinson Disease, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jocelyne Bloch, MD (+41 79 556 29 51, jocelyne.bloch@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From enrollment until end of safety follow-up phase (4 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06295614, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.