Application of Thoracic Epidural SCS for Managing FOG in Patients With Advanced Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
SCS electrode stimulation 1
Device300Hz/300us
SCS electrode stimulation 2
Device130Hz/300us
SCS electrode stimulation 3
Device60Hz/300us
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: SCS implantationExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 72
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.
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 73
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.
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 74
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.
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 7Secondary outcomes
1
Clinical Scale
1. Tinetti Gait Analysis 2. Score: 0-16 (Higher scores means better.)
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 72
Clinical score
1. MDS-UPDRS part III (motor examination) 2. Score: 0-72 (Higher scores means worse.)
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 73
Clinical Scale
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.)
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 74
Clinical Scale
1. Freezing of gait questionnaire 2. Score: 0-26 (Higher scores means worse.)
Time frame
Day 0, Day 2, Day 3, Day 4, and Day 7Sponsors and contacts
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Source ClinicalTrials.gov