Balance and gait impairment increases the risk of falls and contributes to a reduced quality of life and shorter survival in Parkinson disease (PD) and atypical Parkinsonism patients. In preliminary case studies, electrical epidural spinal cord stimulation (SCS) has been shown to significantly improve gait, postural instability, rigidity, and tremor. Controlled studies for optimizing which stimulation settings produce the best clinical response for mobility and gait, and achieving these results chronically are all significant unmet needs. Using quantitative laboratory and mobile technologies to test a range of stimulation settings, this research study aims to determine which SCS parameters or combination of parameters is best suited to effectively alleviate disabling symptoms experienced by each patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient
London Health Sciences Centre
London, Ontario, Canada
RECRUITINGTailored SCS programming
Participants following SCS implantation will undergo 3 programming visits. 9 SCS programs will be tested in a repeated fashion on separate days and at different times of the day (morning vs afternoon). The SCS setting(s) to produce the best motor (gait) response will be used by the participant in-home. SCS device will not be used during this time period.
Time frame: 3 weeks
Changes in spatiotemporal gait measures using objective gait analysis
Spatiotemporal gait parameters known to be affected in parkinsonian syndromes will be analyzed over a 12 month period using gait analysis software. Best SCS setting tailored to each participant's gait symptoms will be assessed at 3-, 6- and 12-months time-points.
Time frame: 12 months
Changes in UPDRS-III scores
UPDRS-III assessment will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points while participants are OFF/ON-dopaminergic medication and OFF/ON SCS.
Time frame: 12 months
Changes in NFOG-Q scores
NFOG-Q scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time frame: 12 months
Changes in PDQ-39 scores
PDQ-39 scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time frame: 12 months
Changes in ABC scores
ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time frame: 12 months
Changes in QoL scores
QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time frame: 12 months
DaTscan imaging
Asymmetry and specific binding ratios (SBRs) of the striatal regions of dopamine transporter from I-123 FP-CIT SPECT images will be quantitatively analyzed from pre-surgery and 12-months of SCS use.
Time frame: 12-months
Proprioception testing
KINARM and lower leg KINARM type of robot collects reaction time, speed, force, accuracy and trajectory using a robotic object hitting game to assess cognitive and motor skills to be conducted pre-surgery, and post-SCS at 3-, 6- and 12-months
Time frame: 12-months
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