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

November 17, 2025 updated by: National Taiwan University Hospital

Application of Thoracic Epidural Spinal Cord Stimulation (SCS) for Managing Freezing of Gait (FOG) in Patients With Advanced Parkinson's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Hsinchu City
      • Hsinchu, Hsinchu City, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital Hsin-Chu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCS implantation
Device: SCS electrode stimulation 1
300Hz/300us
Device: SCS electrode stimulation 2
130Hz/300us
Device: SCS electrode stimulation 3
60Hz/300us

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait parameters --- foot rotation [degtree]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- step length [cm]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- stride length [cm]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- step width [cm]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- stance phase [%]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- swing phase [%]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- double stance phase [%]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- step time [second]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- stride time [second]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- cadence [steps/minute]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7
Gait parameters --- velocity [km/hour]
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
(1)Measured by plantar pressure distribution measurement systems (100 Hz, FDM-T, Zebris Medical GmbH, Germany) with a maximum gait track of 6 meters.
Day 0, Day 2, Day 3, Day 4, and Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Scale
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
  1. Tinetti Gait Analysis
  2. Score: 0-16 (Higher scores means better.)
Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical score
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
  1. MDS-UPDRS part III (motor examination)
  2. Score: 0-72 (Higher scores means worse.)
Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical Scale
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
  1. Time up and Go test
  2. Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.
  3. Score: Time in Seconds (Shorter time means better.)
Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical Scale
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
  1. Freezing of gait questionnaire
  2. Score: 0-26 (Higher scores means worse.)
Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical Scale
Time Frame: Day 0, Day 2, Day 3, Day 4, and Day 7
  1. Activities-specific balance confidence scale
  2. Score:0%-100% (Higher percentage means better.)
Day 0, Day 2, Day 3, Day 4, and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202307093DINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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