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Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury

ConditionsSpinal Cord InjuriesCardiovascular DiseasesCardiopulmonary Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorUniversity of British Columbia

About this trial

The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Resident of British Columbia, Canada with active provincial medical services plan

Male or female, 19-65 years of age

Chronic SCI at or above the T10 spinal cord segment

>1-year post injury or diagnosis, at least 6 months from any spinal surgery.

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcutaneous Spinal Cord Stimulation (tSCS)

    Device

    Transcutaneous spinal cord stimulation (tSCS) will be delivered via a non-invasive central nervous system stimulator TESCoN or SCONE (SpineX Inc., CA - experimental type II medical devices) through self-adhesive electrode(s) placed on the skin between spinous processes over the midline of the vertebral column as the cathode(s) and two rectangular electrodes placed symmetrically on the skin over the iliac crests as anodes. Stimulation will be applied at various waveforms and frequencies (ranging between 1Hz and 90Hz) with and without a carrier frequency. Current amplitude will start at 10mA and proceed incrementally until tolerable or responses plateau. If spasticity occurs or is uncomfortable, the current will be decreased. Specific areas for electrode placement will be examined and prepared to reduce skin impedance. tSCS will be delivered under the supervision of a physician (Dr. Krassioukov/Dr. Berger) by trained doctoral/post-doctoral trainees.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Transcutaneous spinal cord stimulation (tSCS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Circulating endothelial biomarkers in EMV/µL (Park et al., 2023)

Real-time Effect: Change in circulating endothelial biomarkers (i.e., endothelial cell derived microvesicles (EMVs)) before and after real-time tSCS during cardiovascular stress (i.e., head-up tilt test to trigger orthostatic hypotension OH and/or vibrostimulation/DARS to trigger AD). Long-term Effect: Change from baseline in circulating endothelial biomarkers (i.e., endothelial cell derived microvesicles (EMVs)) before and after long-term tSCS intervention during cardiovascular stress (i.e., head-up tilt test to trigger OH and/or vibrostimulation/DARS to trigger AD).

Time frame
Real-time Effect: 1 week; Long-term Effect: 8 weeks

Secondary outcomes

1

Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008)

Real-time Effect: Change in plasma catecholamines (e.g., norepinephrine) before and after real-time tSCS during cardiovascular stress (i.e., head-up tilt test to trigger orthostatic hypotension OH and/or vibrostimulation/DARS to trigger AD). Long-term Effect: Change from baseline in plasma catecholamines (e.g., norepinephrine) before and after long-term tSCS intervention during cardiovascular stress (i.e., head-up tilt test to trigger OH and/or vibrostimulation/DARS to trigger AD).

Time frame
Real-time Effect: 1 week; Long-term Effect: 8 weeks
2

Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FVC

Real-time Effect: Change in spirometric parameters (i.e., forced vital capacity (FVC)), before and after real-time tSCS during cardiovascular stress (i.e., head-up tilt test to trigger orthostatic hypotension OH and/or vibrostimulation/DARS to trigger AD). Long-term Effect: Change from baseline in spirometric parameters (i.e., forced vital capacity (FVC)), before and after long-term tSCS intervention during cardiovascular stress (i.e., head-up tilt test to trigger OH and/or vibrostimulation/DARS to trigger AD).

Time frame
Real-time Effect: 1 week; Long-term Effect: 8 weeks
3

Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FEV1

Real-time Effect: Change in spirometric parameters (i.e., forced expiratory volume (FEV) in 1 second (FEV1)), before and after real-time tSCS during cardiovascular stress (i.e., head-up tilt test to trigger orthostatic hypotension OH and/or vibrostimulation/DARS to trigger AD). Long-term Effect: Change from baseline in spirometric parameters (i.e., forced expiratory volume (FEV) in 1 second (FEV1)), before and after long-term tSCS intervention during cardiovascular stress (i.e., head-up tilt test to trigger OH and/or vibrostimulation/DARS to trigger AD).

Time frame
Real-time Effect: 1 week; Long-term Effect: 8 weeks

Other outcomes

Sponsors and contacts

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

University of British Columbia

Lead sponsor

Source ClinicalTrials.gov

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