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Spinal cord stimulation put to the test for Parkinson's freezing of gait

NCT ID NCT06798844

NEW Symptom relief Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Freezing of gait is a disabling symptom of Parkinson's disease that often does not respond well to current treatments. Researchers are testing whether spinal cord stimulation, a device-based therapy already used for chronic pain, can reduce these freezing episodes. In this trial, 29 people with Parkinson's disease and frequent freezing receive an implanted spinal electrode connected to an external stimulator. Over three weeks, they experience three different stimulation settings in random order, including a sham setting, while wearable sensors and questionnaires track their walking. The study also records spinal and brain signals to understand how the stimulation might work.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spinal cord stimulation using an implanted electrode and neurostimulator
What this could lead to
If it works, spinal cord stimulation could become a new option for people whose Parkinson's freezing of gait does not improve with standard drugs or deep brain stimulation.
What could go wrong
The trial is small and early stage, so any benefit may not hold up in larger studies. Implanting a spinal electrode carries risks such as infection, lead movement, or discomfort, and the sham comparison may show no real difference.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 29 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Freezing of gait Parkinson disease

Contacts and locations

Locations

  • University Hospitals Leuven

    Leuven, 3000, Belgium

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