Using spinal cord stimulation to improve walking in Parkinson's disease
Spinal Cord Stimulation to Reduce Imbalance and Falls in Parkinson's Disease
This study is testing if spinal cord stimulation can help people with Parkinson's disease walk better and improve their balance when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06005584 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of spinal cord stimulation (SCS) on gait and balance in patients with Parkinson's disease who experience significant gait dysfunction resistant to medical therapy. Up to 8 participants will receive an implanted spinal cord stimulator, with stimulation parameters including burst stimulation, high frequency stimulation, and sham stimulation, administered in a randomized order. Assessments will be conducted at baseline and after each stimulation setting to evaluate the impact on posture and gait. The study aims to identify which stimulation parameters provide the most symptomatic relief for participants.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 85 with Parkinson's disease and significant gait dysfunction, particularly freezing of gait, that is resistant to optimal medical therapy.
Not a fit: Patients with atypical parkinsonism, major cognitive or psychiatric illnesses, or significant chronic back pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve walking and reduce falls in patients with Parkinson's disease.
How similar studies have performed: Some open-labelled studies have shown potential benefits of spinal cord stimulation in Parkinson's disease, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London
- Imperial College London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Yen Tai — Imperial College London
- Study coordinator: Yen Tai
- Email: yen.tai@imperial.ac.uk
- Phone: +442033111182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.