Parkinson DiseaseNCT06630702
Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease
A study testing SCS electrode stimulation 1, SCS electrode stimulation 2 and SCS electrode stimulation 3 in people with Parkinson Disease and Freezing of Gait, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait, Spinal Cord Stimulation
- What is being tested?
- SCS electrode stimulation 1, SCS electrode stimulation 2 and SCS electrode stimulation 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, Hsinchu City, 300
Kai-Hsiang Chen, M.D., +886-3-5326151 ext. 522610, stanleychen1230@gmail.com
About this study
Official title: 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.
- Conditions
- Parkinson Disease, Freezing of Gait, Spinal Cord Stimulation
- Being tested
- SCS electrode stimulation 1, SCS electrode stimulation 2, SCS electrode stimulation 3
- Keywords
- Spinal cord stimulation, Freezing of gait, Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCS electrode stimulation 1Device
300Hz/300us
SCS electrode stimulation 2Device
130Hz/300us
SCS electrode stimulation 3Device
60Hz/300us
| Study group | Role | What they receive |
|---|---|---|
| SCS implantation | Experimental | Not described Receives: Device: SCS electrode stimulation 1; Device: SCS electrode stimulation 2; Device: SCS electrode stimulation 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0, Day 2, Day 3, Day 4, and Day 7
Secondary outcomes (5)
Clinical Scale
- Tinetti Gait Analysis
- Score: 0-16 (Higher scores means better.)
Measured: Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical score
- MDS-UPDRS part III (motor examination)
- Score: 0-72 (Higher scores means worse.)
Measured: Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical Scale
- Time up and Go test
- 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.
- Score: Time in Seconds (Shorter time means better.)
Measured: Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical Scale
- Freezing of gait questionnaire
- Score: 0-26 (Higher scores means worse.)
Measured: Day 0, Day 2, Day 3, Day 4, and Day 7
Clinical Scale
- Activities-specific balance confidence scale
- Score:0%-100% (Higher percentage means better.)
Measured: Day 0, Day 2, Day 3, Day 4, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630702
- Sponsor's protocol ID
- 202307093DINC
- Status last verified
- Nov 2025
- First submitted
- 18 Sep 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Thoracic Epidural Spinal Cord Stimulation (SCS) for Managing Freezing of Gait (FOG) in Patients With Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06630702
- Acronym / sponsor ID
- 202307093DINC
- Conditions
- Parkinson Disease, Freezing of Gait, Spinal Cord Stimulation
- Keywords
- Spinal cord stimulation, Freezing of gait, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS implantation | Experimental | Device: SCS electrode stimulation 1, Device: SCS electrode stimulation 2, Device: SCS electrode stimulation 3 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCS electrode stimulation 1300Hz/300us | Device | SCS implantation |
| SCS electrode stimulation 2130Hz/300us | Device | SCS implantation |
| SCS electrode stimulation 360Hz/300us | Device | SCS implantation |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Clinical Scale
Time frame: 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
Clinical Scale
Time frame: 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
Clinical Scale
Time frame: Day 0, Day 2, Day 3, Day 4, and Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCS electrode stimulation 1, SCS electrode stimulation 2 and SCS electrode stimulation 3 in people with Parkinson Disease and Freezing of Gait, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai-Hsiang Chen, M.D. (+886-3-5326151 ext. 522610, stanleychen1230@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameters --- foot rotation [degtree] (time frame: Day 0, Day 2, Day 3, Day 4, and Day 7). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.