National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Hsinchu City, 300, Taiwan
Location status: Recruiting
Recruiting
NCT Number: NCT06630702
Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease
Spinal cord stimulation (SCS) has proven to be effective for pain that is unresponsive to medication. This technique involves an anesthesiologist or a neurosurgeon placing stimulation electrodes at the thoracic vertebrae to provide pain relief. Although SCS is not currently a standard treatment for patients with Parkinson's disease, recent studies have shown that Parkinson's patients who experience intolerable pain and undergo SCS treatment not only experience pain relief but also show improvements in gait and other Parkinson's symptoms. Therefore, the investigators aim to use temporary, minimally invasive SCS electrodes to help patients with nrFOG (non-responsive Freezing of Gait) improve their stability and reduce their risk of falls.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
40 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
SCS electrode stimulation 1
Device300Hz/300us
SCS electrode stimulation 2
Device130Hz/300us
SCS electrode stimulation 3
Device60Hz/300us
Primary outcomes
-
Gait parameters --- foot rotation [degtree]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- step length [cm]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- stride length [cm]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- step width [cm]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- stance phase [%]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- swing phase [%]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- double stance phase [%]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- step time [second]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- stride time [second]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- cadence [steps/minute]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
-
Gait parameters --- velocity [km/hour]
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Secondary outcomes
-
Clinical Scale
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
- Tinetti Gait Analysis
- Score: 0-16 (Higher scores means better.)
-
Clinical score
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
- MDS-UPDRS part III (motor examination)
- Score: 0-72 (Higher scores means worse.)
-
Clinical Scale
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
- Time up and Go test
- Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
- Score: Time in Seconds (Shorter time means better.)
-
Clinical Scale
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
- Freezing of gait questionnaire
- Score: 0-26 (Higher scores means worse.)
-
Clinical Scale
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
- Activities-specific balance confidence scale
- Score:0%-100% (Higher percentage means better.)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Official study title
Application of Thoracic Epidural Spinal Cord Stimulation (SCS) for Managing Freezing of Gait (FOG) in Patients With Advanced Parkinson's Disease
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Oct 8, 2024
- Registry last updated
- Nov 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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