Spinal Cord Stimulation for Gait in Parkinson Disease
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|ClinicalTrials.gov Identifier: NCT03079310|
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Spinal cord stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thoracic Dorsal Spinal Cord Stimulation for the Treatment of Gait and Balance Impairments in Parkinson Disease|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Spinal cord stimulation
Boston Scientific SCS system
Device: Spinal cord stimulation
Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient
Other Name: Boston Scientific Precision® System
- Tailored SCS programming [ Time Frame: 3 weeks ]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.
- Changes in spatiotemporal gait measures using objective gait analysis [ Time Frame: 12 months ]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.
- Changes in UPDRS-III scores [ Time Frame: 12 months ]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.
- Changes in FOG-Q scores [ Time Frame: 12 months ]FOG-Q scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
- Changes in PDQ-8 scores [ Time Frame: 12 months ]PDQ-8 scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
- Changes in ABC scores [ Time Frame: 12 months ]ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
- Changes in QoL scores [ Time Frame: 12 months ]QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079310
|Contact: Mandar Jog, MD||519-685-8500 ext 76708|
|Contact: Olivia Samotus, MSc||519-685-8500 ext 32059|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada, N6A5A5|
|Contact: Mandar Jog, MD 519-685-8500 ext 32758 email@example.com|
|Principal Investigator:||Mandar Jog, MD||LHSC|