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| Name | Class |
|---|---|
| Danish Parkinson Association | OTHER |
| Danish Council for Independent Research | OTHER |
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Patients with PD and SCS treatment for gait impairment entered a cross-over trial of four stimulation paradigms; high frequency/low pulse width, low frequency/high pulse width, Fast-Acting Sub-perception Therapy, and MicroBurst.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High frequency/low pulse width | Active Comparator |
| |
| Low frequency/high pulse width | Active Comparator |
| |
| Fast-Acting Sub-perception Therapy | Active Comparator |
| |
| MicroBurst | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation paradigm: High frequency / low pulse width | Other | High frequency/low pulse width (300 Hz/90 μsec) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postural Instability / Gait Difficulty | MDS-UPDRS subscore (ranging 0-20). Higher score is worse. | From enrollment to the end of the study at eight months. |
| Lower Body Gait score | MDS-UPDRS subscore (ranging 0-36). Higher score is worse. | From enrollment to the end of the study at eight months. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change | Ranging 0-6. Higher score is better. | From enrolment to the end of the study at eight months. |
| New Freezing of Gait Questionnaire | The Danish version ranging 0-30. Higher score is worse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Aarhus | 8000 | Denmark |
Individual data for all outcomes will be provided in Supplementary Materials.
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| Stimulation paradigm: Low frequency / high pulse width | Other | Low frequency/high pulse width (130 Hz/300 μsec) |
|
| MicroBurst | Other | MicroBurst stimulation |
|
| Fast Acting Sub-perception Therapy | Other | FAST |
|
| From enrolment to the end of the study at eight months. |
| Active Balance and Confidence scale | Range 0-100, higher score is better. | From enrolment to the end of the study at eight months. |
| Parkinson's Disease Questionnaire - 39 | Score range from 0-100, higher score is worse. | From enrolment to the end of the study at eight months. |
| Berg Balance Scale | Higher score is better (range 0-56). Total scores below 41 indicate moderate falls risk. | From enrolment to the end of the study at eight months. |
| Gait assessments | Timed TUG, DT, 20-metres walks, and mean figure-of-eight test. Longer time is worse. | From enrolment to the end of the study at eight months. |
| Number of falls | Reported since last visit. Higher number is worse. | From enrolment to the end of the study at eight months. |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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