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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
11
High frequency/low pulse width (300 Hz/90 μsec)
Low frequency/high pulse width (130 Hz/300 μsec)
MicroBurst stimulation
Aarhus University
Aarhus, Denmark
Postural Instability / Gait Difficulty
MDS-UPDRS subscore (ranging 0-20). Higher score is worse.
Time frame: 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.
Time frame: From enrollment to the end of the study at eight months.
Patient Global Impression of Change
Ranging 0-6. Higher score is better.
Time frame: 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.
Time frame: From enrolment to the end of the study at eight months.
Active Balance and Confidence scale
Range 0-100, higher score is better.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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FAST
Time frame: From enrolment to the end of the study at eight months.
Number of falls
Reported since last visit. Higher number is worse.
Time frame: From enrolment to the end of the study at eight months.