Spinal Cord Stimulation for Gait in Parkinson Disease

June 19, 2020 updated by: Western University, Canada

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Recruiting
        • London Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Boston Scientific Precision® System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Changes in NFOG-Q scores
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
12 months
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.
12 months
DaTscan imaging
Time Frame: 12-months
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
Time Frame: 12-months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Investigators

  • Principal Investigator: Mandar Jog, MD, LHSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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