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NCT04325165

DBS of PPN to Improve Walking in Chronic SCI Patients

Withdrawn NA Last updated 3 November 2020
What this trial tests

NA trial testing DBS Implantation in Spinal Cord Injuries. Withdrawn.

Timeline
30 June 2015
Primary endpoint
26 November 2018
26 November 2018

Quick facts

Lead sponsorUniversity Health Network, Toronto
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Start date30 June 2015
Primary completion26 November 2018
Estimated completion26 November 2018

Drugs / interventions tested

Conditions studied

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injuries or Spinal Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
    Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991

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Other recruiting trials for Spinal Cord Injuries

Currently open trials in the same condition.

Other University Health Network, Toronto trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing