---
title: Alleviate gait freezing and instability
nct_id: NCT06295614
phase: NA
status: RECRUITING
sponsor: Ecole Polytechnique Fédérale de Lausanne
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06295614"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06295614"
last_fetched: "2026-05-10T14:01:51.016Z"
source: "Parkinson's Pathways (curated)"
---
# Alleviate gait freezing and instability

**Goal (in five words):** Alleviate gait freezing and instability

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

**Trial ID:** [NCT06295614](https://clinicaltrials.gov/study/NCT06295614)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Ecole Polytechnique Fédérale de Lausanne
- **Target Enrollment:** 6 participants
- **Start Date:** 2024-02-14
- **Completion Date:** 2029-04-01
- **Conditions:** Parkinson Disease
- **Interventions:** ARC-IM System implantation
- **Intervention Types:** DEVICE

## Summary For Families

The goal is to ease severe walking problems in Parkinson's, especially postural instability and freezing of gait, for people who still struggle despite optimal medications. The approach implants the ARC-IM system, a small device that delivers targeted electrical stimulation to the neural circuits that control walking, aiming to improve step initiation, balance, and steadier gait while working alongside levodopa rather than replacing it. The study is enrolling adults 18 and older with typical Parkinson's at Hoehn-Yahr stage II to IV who have persistent gait impairments despite best medical management, can communicate in French or English, and are willing to undergo the implant and follow-up visits. People with atypical Parkinsonism, unstable medical or psychiatric conditions, planned major PD surgeries like DBS, pregnancy, frequent MRI needs, recent substance abuse, or recent experimental treatments are excluded.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full Criteria

```
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.
```

## Locations (1)

- Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Canton of Vaud, Switzerland _(46.5160, 6.6328)_
  - Jocelyne Dr Bloch, Prof. Dr. — (CONTACT)

## Central 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

---

*Canonical: https://parkinsonspathways.com/trial/NCT06295614*  
*HTML version: https://parkinsonspathways.com/trial/NCT06295614*  
*Source data: https://clinicaltrials.gov/study/NCT06295614*