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New treatment option for Freezing of Gait
Official title Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
ClinicalTrials.gov ID: NCT06798844
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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...
- 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...
- Duodopa pump or apomorphine injections
- Fall frequency \>1x/day (this criterion comprises only 'actual falls', no 'near falls')
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.