Clinical trial NCT04325165: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Injuries
Spinal Fractures
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Rehabilitation Institute
First posted: 2020-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Walk assessment
timeFrame: 1 Year
measure: Timed 10-meter walk test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Andres Lozano
role: PRINCIPAL_INVESTIGATOR
References: