---
title: Reduce freezing episodes while walking
nct_id: NCT06570421
phase: NA
status: RECRUITING
sponsor: Stimvia s.r.o.
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06570421"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06570421"
last_fetched: "2026-05-10T14:04:19.116Z"
source: "Parkinson's Pathways (curated)"
---
# Reduce freezing episodes while walking

**Goal (in five words):** Reduce freezing episodes while walking

**Official Title:** 24-months, Open-label, Single-Site Extension Study to Evaluate Safety, Tolerability and Efficacy of the Home-based Peroneal Electrical Transcutaneous NeuroModulation (Peroneal eTNM®) Treatment Via Nerve Stimulator URIS ITM in Treatment of Symptoms Related to Movement Disorders in Subjects With Parkinson's Disease (PD) and Essential Tremor (ET)

**Trial ID:** [NCT06570421](https://clinicaltrials.gov/study/NCT06570421)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Stimvia s.r.o.
- **Target Enrollment:** 20 participants
- **Start Date:** 2024-07-19
- **Completion Date:** 2026-07
- **Conditions:** Parkinson Disease, Essential Tremor
- **Interventions:** Peroneal electrical transcutaneous neuromodulation (peroneal eTNM®)
- **Intervention Types:** DEVICE

## Summary For Families

It's testing whether regular home use of a peroneal nerve stimulator can safely reduce tremor and other movement problems like bradykinesia and rigidity in people with Parkinson's disease or essential tremor over a 24 month extension. The URIS ITM device delivers small electrical pulses through the skin to the peroneal nerve in the lower leg, with the idea that peripheral neuromodulation can alter motor circuit activity to ease tremor and slowness; because it is a non‑drug therapy it does not change levodopa’s pharmacology and participants are asked to keep chronic medication doses stable while effects and side effects are monitored. Adults 18 and older who completed the earlier TS004-PD study and have measurable tremor (grade 1 or higher), with PD participants also showing bradykinesia and rigidity in the on state, can join, while people with implanted electrical devices, seizure disorders, dementia, peripheral neuropathy, recent botulinum toxin, major depression, or pregnancy are excluded.

## Eligibility

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

### Full Criteria

```
Inclusion Criteria:

* Has completed participation in study TS004-PD
* Competent and willing to provide written, informed consent to participate in the study.
* Stable dose of any chronic medications, if applicable, for 30 days prior to study entry
* Willing to comply with study protocol requirements.
* Subject agrees not to participate in another study from 30 days prior the baseline visit until the final study visit.
* For subjects with PD:

  * Bradykinesia in "on" period based on clinical assessment
  * Rigidity in "on" period based on clinical assessment
  * Hand/arm exhibiting tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the MDS-UPDRS tremor score in "on" period
* For subjects with ET:

  * Visible hand/arm and/or foot/leg tremor (resting and/or intentional and/or postural) ≥ grade 1 as assessed by the TETRAS

Exclusion Criteria:

* Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
* Suspected or diagnosed epilepsy or other seizure disorder
* Presence of clinical signs or diagnosis of dementia
* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
* Presence of clinical signs of peripheral neuropathy on lower limbs
* Presence of chorea and/or dyskinesia
* Clinical symptoms or diagnosis of major depressive disorder
* Presence of any other neurodegenerative disease. These may include multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
* Botulinum toxin injection within 6 months prior to study enrollment
* Subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control (these are methods with a failure quotient of \<1% year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). The pregnancy test in urine at Visits 1 needs to be negative in women of childbearing potential.
* Subjects unable to communicate effectively with the investigator and staff
* Life expectancy less than 6 months
* Subject with active malignant disease
* Subject who, in the opinion of the physician, may interfere with optimal participation in the clinical trial or may pose a risk to the subject
* Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol
```

## Locations (1)

- Cerebrovaskulární poradna s.r.o., Ostrava, Czechia _(49.8347, 18.2820)_
  - David Skoloudik, MD, PhD — (CONTACT) — +420 739 782 970 — skoloudik@email.cz

## Central Contacts

- Lukas Peter, Ph.D. — (CONTACT) — +420732745185 — peter@stimvia.com
- Lukas Doskocil — (CONTACT) — +420776721127 — doskocil@stimvia.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT06570421*  
*HTML version: https://parkinsonspathways.com/trial/NCT06570421*  
*Source data: https://clinicaltrials.gov/study/NCT06570421*