Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease

Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease (NCT06798844) is a Phase 2 interventional studying Freezing of Gait and Parkinson Disease, sponsored by Universitaire Ziekenhuizen KU Leuven. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

Freezing of gait (FOG) is a severely disabling gait disorder in Parkinson's disease (PD). Its poor response to current therapies reflects the shortfall in current knowledge on its exact pathophysiology. Case series suggest a therapeutic promise of spinal cord stimulation (SCS) for FOG, but double-blind randomised controlled trials with reliable FOG assessments are lacking. This randomised, double-blind, placebo-controlled cross-over trial aims to define the outcome, safety, optimal stimulation paradigm and underlying mechanism of SCS for FOG in PD, by exploring both clinical and neurophysiological parameters. Twenty-nine PD patients with refractory FOG will receive an implanted SCS lead connected to an external trial stimulator. During a 3-week trial, 3 stimulation paradigms will be tested in random order, including one sham paradigm. SCS outcome on FOG will be evaluated through wearable accelerometers, self-reported questionnaires and a FOG-provoking protocol at home. Spinal electrophysiological recordings will compare neural properties between PD patients with and without FOG and evaluate intra-patient differences (e.g., on/off medication, DBS states). In patients with deep brain stimulation (DBS) including BrainSense technology, the effect of SCS on pathological beta oscillations in the STN will be explored. A subsequent long-term open-label phase will be conducted in those patients who desire a definitive implanted stimulator. This project will provide new insights into the pathophysiology of FOG, pave the way for SCS implementation in clinical practice and enhance future patient selection.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Freezing of Gait and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 29 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Spinal Cord Stimulation

SCS is an established treatment for chronic neuropathic pain and the implantation procedure in this study follows the conventional clinical approach. Under local anaesthesia, a lead electrode is positioned in the spinal epidural space at the Th8-Th10 vertebral levels. The electrode is then connected to an external stimulator (implantable pulse generator, IPG), used for the 3-week external trial stimulation. Upon completion of the core trial, the electrode may either be removed or connected to an internal IPG, after extensive counselling and dependent on the FOG outcome and patient's preference. A subsequent long-term open label phase will evaluate the long-term efficacy and safety of SCS on FOG, with a follow-up period of six months. Electrophysiological recordings of the dorsal spinal cord will be conducted at the end of the external trial stimulation and at the 6-month follow-up.

OTHER

Spinal electrophysiological recordings

The sole purpose of the control groups in this study, is to facilitate the interpretation of spinal cord electrophysiological characteristics in PD freezers by providing a comparison with individuals without the condition.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospitals Leuven

Leuven, Belgium

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06798844), the sponsor (Universitaire Ziekenhuizen KU Leuven), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06798844 clinical trial studying?

Who can participate in NCT06798844?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06798844?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06798844. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06798844. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.