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Testing spinal stimulation for walking difficulties

Researchers check the early safety and movement effects of ARC-IM spinal cord stimulation in people with Parkinson’s.

Testing a treatment or activity · Study reference: NCT06295614

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date)
2024-02-14
Main measurements finished (planned)
2029-04-01
Study finished (planned)
2029-04-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 18 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study title

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

Original description

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.

Further description from the registry

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 reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
ARC-IM System implantation
Phases
NA
Sponsor
Ecole Polytechnique Fédérale de Lausanne
Start date reported by registry
2024-02-14 (actual)

Registry updated: 2026-06-04 · Status last verified by the registry submitter: 2026-06

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Jocelyne Bloch, MD · +41 79 556 29 51 · jocelyne.bloch@chuv.ch

Eduardo Martin Moraud, Prof · +41 21 31 42 455 · Eduardo.Martin-Moraud@chuv.ch

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Recruiting

Jocelyne Dr Bloch, Prof. Dr.

Facility not reported

Switzerland

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.