DBS of PPN to Improve Walking in Chronic SCI Patients

NCT04325165 | Withdrawn

• 1 other identifier: 159038
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Spinal Cord Injuries; Spinal Injuries; Spinal Fractures

Outcome Measures

Primary Outcomes (2)

• 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.

  1 Year

• Timed 10-meter walk test

  Patients are assess by walking speed in metres per second over a 10-metre walk distance.

  1 year

Study Arms (1)

1: Chronic SCI subjects

EXPERIMENTAL

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

Interventions

DBS Implantation DEVICE

Bilateral implantation of PPN DBS electrodes

1: Chronic SCI subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Toronto Rehabilitation Institute: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Injuries; Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Back Injuries; Fractures, Bone

Study Officials

• Andres Lozano

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Dan Family Chair in Neurosurgery

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: March 27, 2020
• Study Start: June 30, 2015
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share