Neuromodulation With Spinal Stimulation Methods
1 other identifier
interventional
24
1 country
2
Brief Summary
This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 22, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2026
CompletedFebruary 10, 2025
February 1, 2025
1.9 years
March 9, 2021
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Motor response
H-reflex input output curve
Immediately after stimulation (within 1-15 min)
Motor evoked potentials
MEP input-output curve
Immediately after stimulation (within 1-15 min)
Secondary Outcomes (2)
Blood pressure
During the procedure/stimulation and up to 15 min after stimulation.
Perception of discomfort due to stimulation
During and after procedure/stimulation and up to 15 min after stimulation.
Study Arms (2)
Spinal cord stimulation
EXPERIMENTALSpinal cord stimulation will be administered to participants for 15 min.
Shamspinal cord stimulation
SHAM COMPARATORSham spinal cord stimulation will be administered to participants for 15 min.
Interventions
transcutaneous spinal stimulation by direct current stimulation
sham transcutaneous spinal stimulation by direct current stimulation
transcutaneous spinal stimulation by electrical pulsed stimulation
sham transcutaneous spinal stimulation by electrical pulsed stimulation
Eligibility Criteria
You may qualify if:
- spinal cord injury C4 to L4
- ability to understand and follow directions
You may not qualify if:
- history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Manitoba
Winnipeg, Manitoba, R3E 0J9, Canada
University of Manitoba
Winnipeg, Manitoba, R3E 0J9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The participant will be connected to the stimulation device(s) but will not know if it has been turned on during each trial. In addition, the person analyzing the outcome data will not be aware of the stimulation status of the participant.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2021
First Posted
February 22, 2024
Study Start
March 1, 2024
Primary Completion
January 31, 2026
Study Completion
February 15, 2026
Last Updated
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- After study completion (May 2022) for one year.
- Access Criteria
- Upon request
Upon request, we will consider making anonymized data available for analysis by other researchers