Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Oct 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called spinal cord stimulation (SCS) to help patients with advanced Parkinson's disease who experience a specific problem known as "freezing of gait" (FOG). FOG can make it difficult for people to walk, leading to falls and loss of stability. The researchers want to see if using small, temporary SCS devices can improve walking and reduce the risk of falls in these patients, especially those who have not found relief from their symptoms through medication.

To participate in this study, individuals should be between 40 and 85 years old and have been diagnosed with Parkinson's disease for more than five years. They should be experiencing freezing of gait that doesn't respond to medication and may also have some lower limb pain. However, people with other types of Parkinson's disease, those who have had spinal cord injuries, or those with certain medical conditions that could complicate the procedure won't be eligible. Participants will receive the SCS treatment, and the hope is that it will help improve their walking and overall quality of life. This trial is currently not yet recruiting, but it aims to explore a new option for managing this challenging symptom of Parkinson's disease.

Gender

ALL

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.