This clinical trial (NCT06630702) at National Taiwan University Hospital is investigating whether temporary, minimally invasive spinal cord stimulation (SCS) electrodes can help patients with Parkinson's disease who experience freezing of gait that does not respond to medication. The study focuses on improving stability and reducing fall risk through three different SCS stimulation parameters, with participant outcomes tracked through detailed gait analysis and standardized clinical assessments over a one-week period.
Pathway Diagram
Mermaid diagram (expand to render)
Trial Overview
| Field | Value |
|-------|-------|
| NCT ID | NCT06630702 |
| Status | RECRUITING |
| Lead Sponsor | National Taiwan University Hospital |
| Start Date | September 20, 2024 |
| Primary Completion | December 31, 2027 |
| Enrollment | 5 participants (estimated) |
| Study Type | Interventional |
| Device | Spinal Cord Stimulation (SCS) electrodes |
Study Description
Spinal cord stimulation (SCS) has proven to be effective for pain that is unresponsive to medication [@nct06630702]. 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 [@nct06630702]. 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 [@nct06630702].
Conditions
This study enrolls patients diagnosed with primary Parkinson's disease who experience freezing of gait that is not responsive to pharmacological intervention. The investigation focuses on the application of spinal cord stimulation as a therapeutic approach for managing these symptoms in individuals with advanced Parkinson's disease.
Intervention
| Arm | Type | Description |
|-----|------|-------------|
| SCS implantation | Experimental | Device: SCS electrode stimulation 1 (300Hz/300us) |
| SCS implantation | Experimental | Device: SCS electrode stimulation 2 (130Hz/300us) |
| SCS implantation | Experimental | Device: SCS electrode stimulation 3 (60Hz/300us) |
Eligibility Criteria
The study targets patients aged 40 to 85 years who have been diagnosed with primary Parkinson's disease by a movement disorder specialist for more than five years. Eligible participants must demonstrate a clear response to dopaminergic medications while experiencing frozen gait that cannot be adequately controlled through pharmacological management alone. Lower limb pain may be present with or without Parkinson's non-motor symptoms, provided no other secondary gait problems are identified.
Patients with atypical Parkinson's disease are excluded from participation. Additional exclusion criteria include spinal cord injuries, medication-controlled frozen gait, expected lesions near the implantation area that could cause spinal canal stenosis or myelopathy (which can be ruled out by MRI), prior surgery or infection near the implantation area, abnormal coagulation function or long-term use of antithrombotic drugs that cannot be stopped, a Clinical Dementia Rating Scale score of 2 or higher, and known allergies to the device developer.
Healthy Volunteers: No | Sex: All | Age Range: 40-85 years
Primary Outcomes
| Measure | Description | Time Frame |
|---------|-------------|-------------|
| Gait parameters — foot rotation | Measured by plantar pressure distribution systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany), max 6m gait track | Day 0, 2, 3, 4, 7 |
| Gait parameters — step length [cm] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — stride length [cm] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — step width [cm] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — stance phase [%] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — swing phase [%] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — double stance phase [%] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — step time [second] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — stride time [second] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — cadence [steps/minute] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
| Gait parameters — velocity [km/hour] | Plantar pressure measurement | Day 0, 2, 3, 4, 7 |
Secondary Outcomes
| Measure | Description | Time Frame |
|---------|-------------|-------------|
| Tinetti Gait Analysis | Score: 0-16 (Higher = better) | Day 0, 2, 3, 4, 7 |
| MDS-UPDRS part III | Motor examination, Score: 0-72 (Higher = worse) | Day 0, 2, 3, 4, 7 |
| Time Up and Go test | Time in seconds (Shorter = better) | Day 0, 2, 3, 4, 7 |
| Freezing of Gait Questionnaire | Score: 0-26 (Higher = worse) | Day 0, 2, 3, 4, 7 |
| Activities-specific Balance Confidence Scale | Score: 0-100% (Higher = better) | Day 0, 2, 3, 4, 7 |
Locations
| Facility | Status | City | Country |
|----------|--------|------|---------|
| National Taiwan University Hospital Hsin-Chu Branch | RECRUITING | Hsinchu | Taiwan |
For more information about this study, please contact Kai-Hsiang Chen, M.D., at +886-3-5326151 ext. 522610 or via email at stanleychen1230@gmail.com.
| Field | Value |
|-------|-------|
| FDA Regulated Device | Yes |
| Is US Export | Yes |
| Has Expanded Access | No |
| Has DMC | No |
Related Pages
This trial is relevant to several related topics including Parkinson's disease and its associated protein parkin, freezing of gait as a clinical manifestation of Parkinson's disease, spinal cord stimulation and deep brain stimulation as therapeutic interventions, movement disorders more broadly, and general Parkinson's disease treatment overview.
References
[Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease (NCT06630702)](https://clinicaltrials.gov/study/NCT06630702)Pathway Diagram
The following diagram shows the key molecular relationships involving Thoracic Epidural SCS for Parkinson's Disease Freezing of Gait (NCT06630702) discovered through SciDEX knowledge graph analysis:
Mermaid diagram (expand to render)