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Withdrawn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
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
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
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
NCT ID
NCT04325165
First Posted
January 6, 2020
Last Updated
November 2, 2020
Sponsor
University Health Network, Toronto
Collaborators
Toronto Rehabilitation Institute
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Withdrawn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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