| 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 |
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.
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.
| 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) |
Healthy Volunteers: No
Sex: All
Age Range: 40-85 years
| 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 |
| 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 |
| Facility | Status | City | Country |
|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch | RECRUITING | Hsinchu | Taiwan |
| Field | Value |
|---|---|
| FDA Regulated Device | Yes |
| Is US Export | Yes |
| Has Expanded Access | No |
| Has DMC | No |