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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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