---
title: Spinal cord stimulation reduces freezing
nct_id: NCT06798844
phase: PHASE2
status: RECRUITING
sponsor: Universitaire Ziekenhuizen KU Leuven
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06798844"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06798844"
last_fetched: "2026-05-10T14:08:28.845Z"
source: "Parkinson's Pathways (curated)"
---
# Spinal cord stimulation reduces freezing

**Goal (in five words):** Spinal cord stimulation reduces freezing

**Official Title:** Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease

**Trial ID:** [NCT06798844](https://clinicaltrials.gov/study/NCT06798844)

## Key Facts

- **Phase:** PHASE2
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Universitaire Ziekenhuizen KU Leuven
- **Target Enrollment:** 29 participants
- **Start Date:** 2025-02
- **Completion Date:** 2027-05
- **Conditions:** Freezing of Gait, Parkinson Disease
- **Interventions:** Spinal Cord Stimulation, Spinal electrophysiological recordings
- **Intervention Types:** DEVICE, OTHER

## Summary For Families

The aim is to reduce freezing of gait, those sudden stops or hesitations that make walking unsafe or unpredictable for people with Parkinson's. An implanted spinal cord stimulator delivers mild electrical pulses to the dorsal spinal cord to modulate sensory and motor signals and help restore stepping rhythm, and the team will record spinal electrophysiology to see how those signals change. The device is tested as an add-on while people stay on stable Parkinson's medications or deep brain stimulation settings, so it does not replace levodopa or DBS but may provide extra control over gait. They are enrolling people 40 to 79 with idiopathic PD who have at least one daily freezing episode, can walk 10 meters unassisted, have reasonably preserved cognition (MoCA ≥19), and are medically eligible for SCS surgery; frequent daily fallers, those with severe chronic back pain or infusion pumps, and people with surgical contraindications are excluded.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 80 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Diagnosis of idiopathic PD in accordance with the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease
* Optimal medical or DBS management for FOG, as evaluated by a movement disorder neurologist and programming expert. Stable PD medication and/or DBS settings for ≥ 1 month prior to baseline assessment and no changes are expected for the next 8 weeks
* Self-reported FOG severity of ≥ 1 FOG episode per day, based on NFOG-Q items 1 and 2
* Presence of FOG during in-hospital clinical assessment consisting of 3 FOG-provoking tasks, in the on-medication state
* Able to walk 10 meters unassisted without a walking aid (use of a cane is allowed)
* Able to understand study requirements and provide consent
* Age 40-79 years inclusive

Exclusion Criteria:

* Presence of other severe neurological, psychiatric or other disorder that may impede assessment of outcomes
* Contra-indications to SCS surgery (e.g. epidural fibrosis, inability to safely discontinue anticoagulant drugs, allergy to implants, medically inoperable)
* Cognitive impairment (Montreal Cognitive Assessment (MOCA) \<19/30)
* Chronic (\>6m) severe (numeric rating scale \>5/10) back or leg pain, or FBSS, as the antalgic effect of SCS could cloud our interpretations for its effect on FOG
* Duodopa pump or apomorphine injections
* Fall frequency \>1x/day (this criterion comprises only 'actual falls', no 'near falls')
* Absence of FOG during preoperative at-home FOG-protocol, in on- or off-medication assessment
* Pregnancy, lactating or active pregnancy plans
```

## Locations (1)

- University Hospitals Leuven, Leuven, Belgium _(50.8796, 4.7009)_
  - Sara Smeets, MD — (CONTACT) — +32 16 344290 — sara.smeets@uzleuven.be
  - Amal El Kaddouri — (CONTACT) — +32 16 344801 — amal.elkaddouri@uzleuven.be
  - Philippe De Vloo, MD, PhD, Prof. — (CONTACT)

## Central Contacts

- Sara Smeets, MD — (CONTACT) — +32 16 344290 — sara.smeets@uzleuven.be
- Amal El Kaddouri — (CONTACT) — +32 16 344801 — amal.elkaddouri@uzleuven.be

---

*Canonical: https://parkinsonspathways.com/trial/NCT06798844*  
*HTML version: https://parkinsonspathways.com/trial/NCT06798844*  
*Source data: https://clinicaltrials.gov/study/NCT06798844*