Spinal Cord Stimulation for Gait in Parkinson Disease

Study Overview
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Brief Summary
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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.

Official Title
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Thoracic Dorsal Spinal Cord Stimulation for the Treatment of Gait and Balance Impairments in Parkinson Disease

Conditions
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Parkinson Disease, Atypical Parkinsonism

Intervention / Treatment
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* Device: Spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting male and female participants, aged 18 years to 80 years Idiopathic PD with II-IV Hoehn-Yahn stage A history of frequent falls, gait and balance dysfunction and postural instability ON-freezing Ability to perform a gait/walking task (under close supervision), PD participants referred by Dr. Jog to the functional neurosurgeon for SCS implantation for treatment of their gait and balance dysfunction and/or for their freezing of gait. SCS eligibility has been confirmed by neurologist and neurosurgeon Patients who receive SCS for their gait and mobility must participate in this study in order to determine which SCS parameters provide the patient with the best outcome for their PD symptoms. able to give informed consent Able to attend all clinic visits and assessments No dementia or psychiatric abnormalities on neuropsychological testing No significant secondary causes (such as cerebrovascular disease, normal pressure hydrocephalus, peripheral neuropathy, severe degenerative lower limb or back disease). we had a few devices to include exploratory trial in atypical PD (MSA, PSP, and CBD confirmed diagnosis from clinic). Exclusion Criteria: History of stroke History of ALS or Myasthenia Gravis Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol). Persons prescribed zonisamide Women reporting that they are pregnant Persons medically unstable with contraindications to SCS will be excluded Previous brain surgery or cardiac pacemaker Eligibility for deep brain stimulation surgery Moderately severe parkinsonism in the context of unstable pharmacological treatment Dementia as assessed by DSM criteria or severe cognitive disturbances Severe psychiatric symptoms (in particular, hallucinations and depression) Bad general health Lack of compliance at follow-up Severe dyskinesias Significant cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal cord stimulation<br>Boston Scientific SCS system | Device: Spinal cord stimulation<br>* Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient<br>* Other names: Boston Scientific Precision® System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tailored 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. | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 months | 
| Changes in ABC scores | ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points. | 12 months | 
| Changes in QoL scores | QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points. | 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. | 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 | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Neuromodulation, Feature extraction, spinal cord stimulation, gait analysis, whole-body kinematics