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DBS of PPN to Improve Walking in Chronic SCI Patients

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ClinicalTrials.gov Identifier: NCT04325165
Recruitment Status : Withdrawn (Recruitment issues)
First Posted : March 27, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
Toronto Rehabilitation Institute
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Injuries Spinal Fractures Device: DBS Implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN) to Improve Walking in Chronic Spinal Cord Injury (SCI) Patients
Actual Study Start Date : June 30, 2015
Estimated Primary Completion Date : November 26, 2018
Actual Study Completion Date : November 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1: Chronic SCI subjects

These subjects will undergo:

  1. Bilateral implantation of PPN DBS electrodes;
  2. Electrical stimulation of the DBS electrodes and
  3. Intensive locomotor training
Device: DBS Implantation
Bilateral implantation of PPN DBS electrodes




Primary Outcome Measures :
  1. Walk assessment [ Time Frame: 1 Year ]
    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.

  2. Timed 10-meter walk test [ Time Frame: 1 year ]
    Patients are assess by walking speed in metres per second over a 10-metre walk distance.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04325165


Sponsors and Collaborators
University Health Network, Toronto
Toronto Rehabilitation Institute
Investigators
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Principal Investigator: Andres Lozano University Health Network, Toronto
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Responsible Party: Andres M. Lozano, Professor and Chairman, Dan Family Chair in Neurosurgery, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04325165    
Other Study ID Numbers: 159038
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Fractures
Spinal Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Back Injuries
Fractures, Bone