Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06295614

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

Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2025-07-11

6

Participants Needed

1

Research Sites

267 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Typical form of Parkinson's Disease with II-IV Hoehn-Yahr stage with standard therapy
  • Debilitating locomotor deficits including gait impairments of 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
  • Use of safe contraception for women of childbearing capacity
  • Agreement to comply with all study conditions and attend all training and visits
  • Signed informed consent before any study procedures
Not Eligible

You will not qualify if you...

  • Atypical forms of Parkinson's Disease such as Multiple System Atrophy or Progressive Supranuclear Palsy
  • Secondary causes of gait problems unrelated to Parkinson's Disease
  • Inability to follow study procedures
  • Unstable or significant medical condition interfering with study or evaluations
  • History of major psychiatric or neurocognitive disorders
  • Planned major change in Parkinson's treatment during the main study phase
  • Conditions increasing risk from implantation surgery
  • Spinal abnormalities preventing surgery
  • Drug or alcohol abuse in past 5 years
  • Life expectancy less than 12 months
  • Pregnant, breastfeeding, or intending pregnancy during study
  • Need for frequent Magnetic Resonance Imaging (MRI)
  • Experimental treatment in past 5 years
  • Participation in another interventional study
  • Investigator and related persons' enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

Loading map...

Research Team

J

Jocelyne Bloch, MD

CONTACT

E

Eduardo Martin Moraud, Prof

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here