Clinical trial NCT06630702: Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease
Official title: Application of Thoracic Epidural Spinal Cord Stimulation (SCS) for Managing Freezing of Gait (FOG) in Patients With Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Freezing of Gait
Spinal Cord Stimulation
Keywords: Spinal cord stimulation, Freezing of gait
Parkinson Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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\&#39;s disease, recent studies have shown that Parkinson\&#39;s patients who experience intolerable pain and undergo SCS treatment not only experience pain relief but also show improvements in gait and other Parkinson\&#39;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.


Eligibility criteria: Inclusion Criteria:

* Age:40-85 years old.
* Patients with primary Parkinson\&amp;amp;#39;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\&#39;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.

Primary outcomes:
measure: Gait parameters --- foot rotation [degtree]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- step length [cm]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- stride length [cm]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- step width [cm]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- stance phase [%]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- swing phase [%]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- double stance phase [%]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- step time [second]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- stride time [second]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- cadence [steps/minute]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Gait parameters --- velocity [km/hour]
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
Secondary outcomes:
measure: Clinical Scale
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Clinical score
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Clinical Scale
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Clinical Scale
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
measure: Clinical Scale
timeFrame: Day 0, Day 2, Day 3, Day 4, and Day 7
Other outcomes:
Locations:
Study officials:
References: