NCT06630702 Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease
| NCT ID | NCT06630702 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2024-09-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2024-09-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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'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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06630702 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06630702 currently recruiting?
Yes, NCT06630702 is actively recruiting participants. Contact the research team at stanleychen1230@gmail.com for enrollment information.
Where is the NCT06630702 trial being conducted?
This trial is being conducted at Hsinchu, Taiwan.
Who is sponsoring the NCT06630702 clinical trial?
NCT06630702 is sponsored by National Taiwan University Hospital. The trial plans to enroll 5 participants.
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