Health TrialsbyHealthPanel

Neuromodulation With Spinal Stimulation Methods

ConditionsSpinal Cord InjuriesSpinal Cord Injury at C5-C7 LevelParaplegia, SpinalParaplegia, Incomplete
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

spinal cord injury C4 to L4

ability to understand and follow directions

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • spinal stimulation-DCS

    Device

    transcutaneous spinal stimulation by direct current stimulation

  • spinal stimulation-sham DCS

    Other intervention

    sham transcutaneous spinal stimulation by direct current stimulation

  • spinal stimulation-EPS

    Other intervention

    transcutaneous spinal stimulation by electrical pulsed stimulation

  • sham spinal stimulation-EPS

    Other intervention

    sham transcutaneous spinal stimulation by electrical pulsed stimulation

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Spinal cord stimulationExperimental treatment 2 interventions
Group B: Shamspinal cord stimulationSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Motor response

H-reflex input output curve

Time frame
Immediately after stimulation (within 1-15 min)
2

Motor evoked potentials

MEP input-output curve

Time frame
Immediately after stimulation (within 1-15 min)

Secondary outcomes

1

Blood pressure

Measured (in arm) with inflatable cuff-automated, standard machine.

Time frame
During the procedure/stimulation and up to 15 min after stimulation.
2

Perception of discomfort due to stimulation

self-reporting on a scale ( the higher, the more discomfort)

Time frame
During and after procedure/stimulation and up to 15 min after stimulation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Source ClinicalTrials.gov
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