Actively Recruiting
Application of Thoracic Epidural Spinal Cord Stimulation for Managing Freezing of Gait in Patients With Advanced Parkinson's Disease
Led by National Taiwan University Hospital · Updated on 2025-11-20
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the use of spinal cord stimulation (SCS) to help patients with advanced Parkinson's disease who experience non-responsive Freezing of Gait (nrFOG), a condition where usual medications do not control gait freezing. This approach is being studied because SCS has shown promise in relieving pain and improving motor symptoms in Parkinson's patients. The study aims to evaluate if temporary, minimally invasive thoracic epidural SCS electrodes can improve stability and reduce fall risk in these patients. The study involves placing stimulation electrodes in the thoracic spine area to provide electrical pulses at different frequencies (300Hz, 130Hz, and 60Hz) to assess their effects. Participants will receive SCS electrode stimulation with these settings to observe changes in gait and balance. This is an interventional device study conducted by National Taiwan University Hospital, starting September 2024 and continuing through December 2027. Participants will be monitored closely over a week, with gait parameters such as foot rotation, step length, stride length, step width, stance and swing phases, double stance phase, step and stride time, cadence, and velocity measured on Days 0, 2, 3, 4, and 7. Clinical scales and scores will also be assessed at these intervals. The study aims to track improvements or changes in walking stability and Parkinson's symptoms during this period to evaluate the impact of SCS treatment.
CONDITIONS
Brief Title
Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 85 years old
- Diagnosed with primary Parkinson's disease by a movement disorder specialist for more than 5 years
- Have a frozen gait that cannot be controlled by medication
- May have lower limb pain with or without Parkinson's non-motor symptoms
- No other secondary gait problems
You will not qualify if you...
- Atypical Parkinson's disease
- Presence of spinal cord injuries
- Frozen gait controlled by medication
- Lesions near implantation area causing spinal canal stenosis or myelopathy
- Previous surgery or infection near implantation area affecting implantation success or increasing complication risks
- Abnormal blood clotting or use of long-term antithrombotic drugs that cannot be stopped shortly
- Clinical Dementia Rating Scale score greater than 2.8
- Allergy to developer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo thoracic epidural spinal cord stimulation device implantation as part of the trial treatment.
1 implantation visit
Duration - 7 days
Participants receive spinal cord stimulation at different frequencies to manage freezing of gait symptoms.
Visits on Day 0, Day 2, Day 3, Day 4, and Day 7
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Hsinchu City, Taiwan, 300
Actively Recruiting
Research Team
K
Kai-Hsiang Chen, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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