NCT06630702

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
20mo left

Started Sep 2024

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2024Dec 2027

First Submitted

Initial submission to the registry

September 18, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

September 18, 2024

Last Update Submit

November 17, 2025

Conditions

Parkinson DiseaseFreezing of GaitSpinal Cord Stimulation

Keywords

Spinal cord stimulation, Freezing of gaitParkinson Disease

Outcome Measures

Primary Outcomes (11)

  • Gait parameters --- foot rotation [degtree]

    (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]

    (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]

    (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]

    (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 [%]

    (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 [%]

    (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 [%]

    (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]

    (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]

    (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]

    (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]

    (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 Outcomes (5)

  • Clinical Scale

    Day 0, Day 2, Day 3, Day 4, and Day 7

  • Clinical score

    Day 0, Day 2, Day 3, Day 4, and Day 7

  • Clinical Scale

    Day 0, Day 2, Day 3, Day 4, and Day 7

  • Clinical Scale

    Day 0, Day 2, Day 3, Day 4, and Day 7

  • Clinical Scale

    Day 0, Day 2, Day 3, Day 4, and Day 7

Study Arms (1)

SCS implantation

EXPERIMENTAL
Device: SCS electrode stimulation 1Device: SCS electrode stimulation 2Device: SCS electrode stimulation 3

Interventions

SCS electrode stimulation 1DEVICE

300Hz/300us

SCS implantation
SCS electrode stimulation 2DEVICE

130Hz/300us

SCS implantation
SCS electrode stimulation 3DEVICE

60Hz/300us

SCS implantation

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Hsinchu City, 300, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Kai-Hsiang Chen, M.D.

CONTACT

+886-3-5326151stanleychen1230@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2024

First Posted

October 8, 2024

Study Start

September 20, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

TW(1)