Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spinal Cord Stimulation for Gait in Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079310
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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) 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 PD patient.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Spinal cord stimulation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Mandar Jog, MD 519-685-8500 ext 76708
Contact: Olivia Samotus, MSc 519-685-8500 ext 32059

Locations
Layout table for location information
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A5A5
Contact: Mandar Jog, MD    519-685-8500 ext 32758    mandar.jog@lhsc.on.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
Layout table for investigator information
Principal Investigator: Mandar Jog, MD LHSC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Layout table for additonal information
Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03079310     History of Changes
Other Study ID Numbers: 107451
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Western University, Canada:
spinal cord stimulation
gait analysis
whole-body kinematics
 Parkinson's disease
Neuromodulation
Feature extraction
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases