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Spinal Cord Stimulation for Gait in Parkinson Disease

Primary Purpose

Parkinson Disease, Atypical Parkinsonism

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spinal cord stimulation
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring spinal cord stimulation, gait analysis, whole-body kinematics, Parkinson's disease, Neuromodulation, Feature extraction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal cord stimulation

Arm Description

Boston Scientific SCS system

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Changes in NFOG-Q scores
NFOG-Q scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Changes in PDQ-39 scores
PDQ-39 scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Changes in ABC scores
ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Changes in QoL scores
QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
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.
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

Full Information

First Posted
March 8, 2017
Last Updated
June 19, 2020
Sponsor
Western University, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03079310
Brief Title
Spinal Cord Stimulation for Gait in Parkinson Disease
Official Title
Thoracic Dorsal Spinal Cord Stimulation for the Treatment of Gait and Balance Impairments in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Atypical Parkinsonism
Keywords
spinal cord stimulation, gait analysis, whole-body kinematics, Parkinson's disease, Neuromodulation, Feature extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal cord stimulation
Arm Type
Experimental
Arm Description
Boston Scientific SCS system
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation
Other Intervention Name(s)
Boston Scientific Precision® System
Intervention Description
Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient
Primary Outcome Measure Information:
Title
Tailored SCS programming
Description
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
Title
Changes in spatiotemporal gait measures using objective gait analysis
Description
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
Secondary Outcome Measure Information:
Title
Changes in UPDRS-III scores
Description
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
Title
Changes in NFOG-Q scores
Description
NFOG-Q scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time Frame
12 months
Title
Changes in PDQ-39 scores
Description
PDQ-39 scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time Frame
12 months
Title
Changes in ABC scores
Description
ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time Frame
12 months
Title
Changes in QoL scores
Description
QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
Time Frame
12 months
Title
DaTscan imaging
Description
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
Title
Proprioception testing
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mandar Jog, MD
Phone
519-685-8500
Ext
76708
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Samotus, MSc
Phone
519-685-8500
Ext
32059
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mandar Jog, MD
Organizational Affiliation
LHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandar Jog, MD
Phone
519-685-8500
Ext
32758
Email
mandar.jog@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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21039949
Citation
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Spinal Cord Stimulation for Gait in Parkinson Disease

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