Status:
WITHDRAWN
DBS of PPN to Improve Walking in Chronic SCI Patients
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Toronto Rehabilitation Institute
Conditions:
Spinal Cord Injuries
Spinal Injuries
Eligibility:
All Genders
18-65 years
Phase:
NA
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 g...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04325165
Start Date
June 30 2015
End Date
November 26 2018
Last Update
November 3 2020
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