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

NCT ID: NCT06630702

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2027-12-31

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.

Conditions

Parkinson Disease; Freezing of Gait; Spinal Cord Stimulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCS implantation

Group Type: EXPERIMENTAL

SCS electrode stimulation 1

Intervention Type: DEVICE

300Hz/300us

SCS electrode stimulation 2

Intervention Type: DEVICE

130Hz/300us

SCS electrode stimulation 3

Intervention Type: DEVICE

60Hz/300us

Interventions

SCS electrode stimulation 1

300Hz/300us

Intervention Type: DEVICE

SCS electrode stimulation 2

130Hz/300us

Intervention Type: DEVICE

SCS electrode stimulation 3

60Hz/300us

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Hsinchu City, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Kai-Hsiang Chen, M.D.

Role: CONTACT

stanleychen1230@gmail.com

+886-3-5326151 ext. 522610

Facility Contacts

Kai-Hsiang Chen, M.D.

Role: primary

stanleychen1230@gmail.com

+886-3-5326151 ext. 522610

Other Identifiers

202307093DINC

Identifier Type: -

Identifier Source: org_study_id