An interventional study of Transcutaneous Spinal Cord Stimulation (tSCS) in Spinal Cord Injuries, Cardiovascular Diseases and Cardiopulmonary Diseases, sponsored by University of British Columbia. Not yet recruiting at 1 site in Canada. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
DETAILED RESEARCH PROCEDURES
(A) INFORMED CONSENT:
Prospective participants will be provided with the study informed consent form and will be given at least 24 hours to review the form, ask questions, and discuss with whomever they like.
(B) VISIT 1 -Screening
Approximately 1 hour
Individuals who agree to participate in the study will be invited for a screening assessment to confirm study eligibility. After the individual has provided informed consent, they will be assigned a unique study identification number and the information listed below will be collected.
Screening questionnaires and assessments:
(C) VISITS 2-5 -Baseline functional assessments, questionnaires, and cardiopulmonary assessments
Approximately 2 hours per visit
Enrolled participants will complete questionnaires after which a spirometry assessment for pulmonary function will be performed. Participants will be provided with a 24-hour Ambulatory Blood Pressure Monitor (24- ABPM) device to take home to record daily changes in cardiovascular parameters.
Questionnaires (Visit 2):
Baseline cardiopulmonary and optional functional assessments (with and without tSCS) (Visits 2-5):
Participants will also be provided with instructions to prepare for Visit 3 or 6 (depending on whether they do the optional assessments), during which blood samples will be collected. Participants will be asked to:
(D) VISITS 3-5 or 6-8 (depending on whether or not the optional functional assessments were completed earlier in the study). Baseline cardiovascular assessments and blood draws.
Approximately 3 hours
In this session, participants will return the 24-hour ABP and ECG Monitor and undergo baseline cardiovascular assessments as well as the blood draws. The participant has the option of only taking part in one or all cardiovascular assessments. If the participant chooses to undergo more than one cardiovascular assessment they will be conducted on different visits.
Cardiovascular Assessments:
Blood Draws:
Four (4) blood draws will be taken:
(E) TREATMENT VISITS (minimum 12 tSCS visits, depending on whether or not the optional functional and cardiovascular assessments were done earlier in the study) to completion of long-term intervention with tSCS intervention:
Each session will last approximately 90 minutes (set-up AND at least 45min of tSCS treatment).
Long-term tSCS is scheduled to last for a minimum of two times per week for 6 weeks.
Following the completion of the intervention, participants will begin post-intervention questionnaires and cardiopulmonary assessments. Week to week variation in the number of scheduled sessions may vary due to varying circumstances (e.g., scheduling, transportation, participant health). However, the total number of sessions conducted will be the same as the participant's original goal.
(F) SECOND TO LAST VISIT: Post-intervention questionnaires and cardiopulmonary assessment:
Approximately 2 hours
In this session, participants will complete post-intervention questionnaires and undergo post-intervention cardiopulmonary assessments.
Questionnaires:
Cardiopulmonary Assessments:
(G) LAST VISIT: Post-intervention cardiovascular assessments and blood draws:
Approximately 3 hours
In this session, participants will undergo post-intervention cardiovascular assessments as well as the blood draws.
Cardiovascular Assessments:
Blood Draws:
Four (4) blood draws will be taken:
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 22 is close to the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
INCLUSION \& EXCLUSION CRITERIA:
INCLUSION CRITERIA:
A participant must meet all of the following criteria in order to be eligible for inclusion:
Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
7.1 Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
7.2 Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
EXCLUSION CRITERIA:
A participant who meets any of the following criteria will not be eligible to participate:
Exploring the mechanisms of SCS for improving cardiovascular function in individuals with chronic, motor-complete SCI by measuring vascular related endothelial biomarkers and plasma catecholamines
Device: Transcutaneous Spinal Cord Stimulation (tSCS)
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.
Also known as: TESCoN device by SpineX Inc., CA, USA - experimental type II medical device, SCONE device by SpineX Inc., CA, USA - experimental type II medical device
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
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
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
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
Plan to share: Yes — The research team plans to deposit final de-identified research data at a community-based repository for SCI research, such as Open Data Commons for SCI (https://odc-sci.org//). Research resources, including but not limited to, established stimulation parameter and recording equipment, will also be made available through material transfer agreement upon reasonable request.
Supporting information: Study protocol, Sap, Analytic code
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University of British Columbia