Parkinson's Disease (PD), Spinal Cord Stimulation (SCS)
Conditions
Brief summary
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.
Interventions
OTHERStimulation paradigm: High frequency / low pulse width
High frequency/low pulse width (300 Hz/90 μsec)
OTHERStimulation paradigm: Low frequency / high pulse width
Low frequency/high pulse width (130 Hz/300 μsec)
OTHERMicroBurst
MicroBurst stimulation
OTHERFast Acting Sub-perception Therapy
FAST
Sponsors
University of Aarhus
Danish Parkinson Association
Danish Council for Independent Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants who completed the open extension phase of STEP-PD and still had SCS
Exclusion criteria
* MoCA \<23
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postural Instability / Gait Difficulty | From enrollment to the end of the study at eight months. | MDS-UPDRS subscore (ranging 0-20). Higher score is worse. |
| Lower Body Gait score | From enrollment to the end of the study at eight months. | MDS-UPDRS subscore (ranging 0-36). Higher score is worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Change | From enrolment to the end of the study at eight months. | Ranging 0-6. Higher score is better. |
| New Freezing of Gait Questionnaire | From enrolment to the end of the study at eight months. | The Danish version ranging 0-30. Higher score is worse. |
| Active Balance and Confidence scale | From enrolment to the end of the study at eight months. | Range 0-100, higher score is better. |
| Parkinson's Disease Questionnaire - 39 | From enrolment to the end of the study at eight months. | Score range from 0-100, higher score is worse. |
| Berg Balance Scale | From enrolment to the end of the study at eight months. | Higher score is better (range 0-56). Total scores below 41 indicate moderate falls risk. |
| Gait assessments | From enrolment to the end of the study at eight months. | Timed TUG, DT, 20-metres walks, and mean figure-of-eight test. Longer time is worse. |
| Number of falls | From enrolment to the end of the study at eight months. | Reported since last visit. Higher number is worse. |
Countries
Denmark
Outcome results
None listed