Thoracic epidural spinal cord stimulation to reduce freezing of gait in advanced Parkinson's disease
Application of Thoracic Epidural Spinal Cord Stimulation (SCS) for Managing Freezing of Gait (FOG) in Patients With Advanced Parkinson's Disease
This study will try temporary thoracic spinal cord stimulation to see if it helps people with advanced Parkinson's disease whose freezing of gait does not respond to medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Hsinchu, Hsinchu City) |
| Trial ID | NCT06630702 on ClinicalTrials.gov |
What this trial studies
Investigators will place temporary, minimally invasive thoracic epidural stimulation electrodes and test different stimulation settings to see if gait stability and freezing episodes improve. The trial enrolls people aged 40–85 with primary Parkinson's disease for more than five years who have medication-refractory freezing of gait and no other secondary gait disorders. Outcomes will include measures of gait, freezing frequency, fall risk, and safety during and after temporary stimulation. The procedures are performed at a single center (National Taiwan University Hospital Hsin-Chu Branch) with exclusions for spinal canal stenosis, prior surgery or infection near the implantation site, atypical Parkinsonism, and spinal cord injury.
Who should consider this trial
Good fit: Ideal candidates are 40–85-year-old patients with primary Parkinson's disease of more than five years who have freezing of gait that does not respond to medications and no secondary gait problems or spinal conditions that would block electrode placement.
Not a fit: Patients with atypical Parkinsonism, medication-controlled freezing of gait, spinal cord injuries, significant spinal stenosis or myelopathy at the implantation site, prior surgery or infection near the target area, or other major comorbidities are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, temporary thoracic epidural SCS could improve walking stability and reduce falls in people with medication-refractory freezing of gait.
How similar studies have performed: Small case series and preliminary reports have shown gait and symptom improvements after spinal cord stimulation in Parkinson's patients, but the approach remains experimental and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age:40-85 years old. * Patients with primary Parkinson\'s disease who have been diagnosed by a movement disorder specialist for more than 5 years. Although they have a clear response to drugs, they have a frozen gait that cannot be controlled by drugs. Lower limb pain may be present with or without Parkinson\'s non-motor symptoms. * No other secondary gait problems. Exclusion Criteria: * Atypical Parkinson's disease. * Patients with spinal cord injuries. * Medication-controlled frozen gait. * It is expected that there are lesions near the implantation area causing spinal canal stenosis or myelopathy (can be ruled out by MRI). * It is expected that the implantation area has undergone previous surgery or there is infection near the implantation area, which may affect the success rate of implantation or increase concerns about complications (such as severe extraspinal adhesion, or spinal cord damage in previous surgeries). * People with abnormal coagulation function (such as hemophilia patients) or those who have been controlled by long-term use of antithrombotic drugs and cannot stop taking them in a short period of time. * CDR (Clinical Dementia Rating Scale) ≧2. 8. Those who are allergic to developer.
Where this trial is running
Hsinchu, Hsinchu City
- National Taiwan University Hospital Hsin-Chu Branch — Hsinchu, Hsinchu City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Kai-Hsiang Chen, M.D.
- Email: stanleychen1230@gmail.com
- Phone: +886-3-5326151
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.