Spinal Cord Stimulation for Gait Dysfunction in Parkinson's Disease

Launched by IMPERIAL COLLEGE LONDON · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how spinal cord stimulation (SCS) can help people with Parkinson’s disease (PD) who have trouble walking, especially those who experience "freezing of gait," where they suddenly feel like their feet are glued to the floor. Parkinson's disease affects movement and balance, leading to a higher risk of falls, which can be very serious. The researchers want to see if SCS can improve walking and balance in these patients, as current treatments are not always effective.

To participate in the trial, individuals need to be between 45 and 85 years old and have a confirmed diagnosis of Parkinson's disease along with significant walking difficulties that haven't improved with other treatments. Participants will undergo a small surgery to have the spinal cord stimulator placed, and after a month, they will begin the stimulation therapy. Throughout the study, they will experience different types of stimulation, some of which might not be active, without knowing which ones they are receiving. This helps ensure that the results are reliable. The study is currently looking for volunteers who meet these criteria and can provide informed consent.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.