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DBS of PPN to Improve Walking in Chronic SCI Patients

Primary Purpose

Spinal Cord Injuries, Spinal Injuries, Spinal Fractures

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DBS Implantation
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 to 65 (at time of enrolment)
  • SCI that occurred greater than 2 years ago
  • Current neurological status of AIS grade C or D, can stand with aids but not functionally ambulate
  • Residence in GTA

Exclusion Criteria:

  • Other substantial medical conditions causing physical restrictions, neurological deficits, or causing excessive risk of surgery
  • Professional or other time commitments affecting availability for numerous hospital visits
  • Contraindications to MRI (eg. metal in eye)
  • Women that are pregnant (according to a bHCG serum/urine test at time of screening), or are actively seeking to become pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1: Chronic SCI subjects

    Arm Description

    These subjects will undergo: Bilateral implantation of PPN DBS electrodes; Electrical stimulation of the DBS electrodes and Intensive locomotor training

    Outcomes

    Primary Outcome Measures

    Walk assessment
    Patients are assess by how a person walks or move their limbs. Patients will be asked to walk on a mat while the system captures gait patterns for both time (temporal) and space (spatial) through pressure sensors in a mat located in a walkway.
    Timed 10-meter walk test
    Patients are assess by walking speed in metres per second over a 10-metre walk distance.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 6, 2020
    Last Updated
    November 2, 2020
    Sponsor
    University Health Network, Toronto
    Collaborators
    Toronto Rehabilitation Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04325165
    Brief Title
    DBS of PPN to Improve Walking in Chronic SCI Patients
    Official Title
    Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) to Improve Walking in Chronic Spinal Cord Injury (SCI) Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Recruitment issues
    Study Start Date
    June 30, 2015 (Actual)
    Primary Completion Date
    November 26, 2018 (Anticipated)
    Study Completion Date
    November 26, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Health Network, Toronto
    Collaborators
    Toronto Rehabilitation Institute

    4. Oversight

    5. Study Description

    Brief Summary
    Spinal cord injury (SCI) is a devastating condition affecting over 1 million individuals in North America. SCI often results in severe motor impairments with few available treatments options. Recent groundbreaking research has demonstrated that deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR) greatly improves locomotion in a rat model with incomplete SCI. The pedunculopontine nucleus (PPN - a specific nucleus within the MLR) in humans has already been established as an auxillary DBS target in Parkinson Disease (PD), to improve motor control and locomotion. DBS of other targets has also been safely used in humans with SCI for chronic pain. These findings suggest that DBS of the PPN may have potential as a therapeutic intervention in the SCI population to improve locomotion. Our goal is to conduct a pioneering study in 5 select motor-incomplete chronic SCI patients that cannot functionally ambulate to examine if bilateral DBS of the PPN improves walking
    Detailed Description
    This prospective repeated measures study of the implantation of bilateral PPN electrodes in a small series of chronic SCI patients will aim to examine safety, feasibility, and potential efficacy. This research will investigate the effects of electrode implantation, electrical stimulation and intensive locomotion training over a 1-year period. Motor assessments will be performed at regular intervals with stimulation on and off in a double-blind fashion (subjects and researchers will be unaware of stimulation setting), to determine if subjects have improved ambulation with stimulation on compared with off, and if their ambulation improves over the course of the study observation period with stimulation on.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries, Spinal Injuries, Spinal Fractures

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1: Chronic SCI subjects
    Arm Type
    Experimental
    Arm Description
    These subjects will undergo: Bilateral implantation of PPN DBS electrodes; Electrical stimulation of the DBS electrodes and Intensive locomotor training
    Intervention Type
    Device
    Intervention Name(s)
    DBS Implantation
    Intervention Description
    Bilateral implantation of PPN DBS electrodes
    Primary Outcome Measure Information:
    Title
    Walk assessment
    Description
    Patients are assess by how a person walks or move their limbs. Patients will be asked to walk on a mat while the system captures gait patterns for both time (temporal) and space (spatial) through pressure sensors in a mat located in a walkway.
    Time Frame
    1 Year
    Title
    Timed 10-meter walk test
    Description
    Patients are assess by walking speed in metres per second over a 10-metre walk distance.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 to 65 (at time of enrolment) SCI that occurred greater than 2 years ago Current neurological status of AIS grade C or D, can stand with aids but not functionally ambulate Residence in GTA Exclusion Criteria: Other substantial medical conditions causing physical restrictions, neurological deficits, or causing excessive risk of surgery Professional or other time commitments affecting availability for numerous hospital visits Contraindications to MRI (eg. metal in eye) Women that are pregnant (according to a bHCG serum/urine test at time of screening), or are actively seeking to become pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andres Lozano
    Organizational Affiliation
    University Health Network, Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    DBS of PPN to Improve Walking in Chronic SCI Patients

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