Status:
RECRUITING
Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease
Lead Sponsor:
Imperial College London
Conditions:
Parkinson Disease
Freezing of Gait
Eligibility:
All Genders
45-85 years
Phase:
NA
Brief Summary
Parkinson's disease (PD) is the second commonest neurodegenerative disorder, affecting over 145,000 people in the UK. Initially, PD patients experience slowness of movements, limb stiffness, and tremo...
Detailed Description
The investigators aim to recruit up to 8 people with Parkinson's with significant gait dysfunction which is resistant to medical therapy to this study. All participants will receive implantation of a ...
Eligibility Criteria
Inclusion
- Age: 45 ≤ X ≤ 85
- PD diagnosis based on UK Parkinson's disease society brain bank criteria
- Significant gait dysfunction, particularly freezing of gait, which is resistant to optimal medical therapy
- Hoen and Yahr stage: 2-4 (in ON state)
- Stable dopaminergic treatment for at least two weeks before enrolment.
- Can provide informed consent
Exclusion
- Atypical or secondary parkinsonism e.g. vascular, drug-induced
- Major focal brain disorders (including malignancy or stroke)
- Recent (within 3 months)/current use of acetylcholinesterase inhibitors or antidopaminergic drugs
- Concomitant treatment with deep brain stimulation
- Neurological, vestibular, visual or orthopaedic diagnosis significantly interfering with gait
- Pregnant women or planning to become pregnant
- Significant chronic back pain
- Spinal anatomical abnormalities precluding SCS surgery
- Major cognitive or psychiatric illness
- Concomitant or recent (less than 4 months) enrolment in an interventional research trial.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06005584
Start Date
June 1 2023
End Date
February 28 2026
Last Update
August 22 2023
Active Locations (1)
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1
Imperial College London
London, United Kingdom