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Spinal Cord InjuriesNCT06379711

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

A study testing Transcutaneous Spinal Cord Stimulation (tSCS) in people with Spinal Cord Injuries and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 19 to 65 years
What is being tested?
Transcutaneous Spinal Cord Stimulation (tSCS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
1 Aug 2024to 1 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A participant must meet all of the following criteria in order to be eligible for inclusion:
  • 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.
  • American Spinal Injury Association Impairment Scale (AIS) A, B, C and D for SCI
Show all 14Show fewer
  • Stable management of spinal cord related clinical issues (e.g., spasticity management)
  • 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.
  • Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
  • Must provide informed consent.
  • Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
  • Willing and able to comply with all clinic visits and study-related procedures.

Who cannot join

  • A participant who meets any of the following criteria will not be eligible to participate:
  • Ventilator dependent.
  • Painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing
  • Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
  • Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
  • Intrathecal baclofen pump.
Show all 12Show fewer
  • Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
  • Presence of severe acute medical issue(s) that in the investigator's judgement would adversely affect the participant's participation in the study (e.g., pressure sore, urinary tract infection, etc.).
  • Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
  • Severe anemia (Hgb<8 g/dl) or hypovolemia as measured by hematocrit via blood test in the last six months.
  • Participant has undergone electrode implantation surgery.
  • Participant is a member of the investigational team or his/her immediate family.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Maharaj, BSc contact

6046758856

amaharaj@icord.org

Canada1 site

  • Blusson Spinal Cord Centre

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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.

Read the detailed description

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:

  • Inclusion/Exclusion Criteria confirmation
  • Demographics
  • Medical history and history of injury
  • Concomitant medication use
  • Weight and height
  • Previous allergies and adverse events to medications
  • Pregnancy screening will be performed
  • Internationals Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam (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):

  • Short-form (36) Health Survey (SF-36)
  • Autonomic Dysfunction following SCI (ADFSCI) questionnaire
  • Leisure Time Physical Activity Questionnaire after SCI (LTPAQ-SCI).
  • National Health Interview Survey - Chronic Conditions
  • American Thoracic Society (ATS) Adult Respiratory Disease Survey. - Tobacco Use

Baseline cardiopulmonary and optional functional assessments (with and without tSCS) (Visits 2-5):

  • Spirometry testing (Visit 2)
  • 24-hour Ambulatory Blood Pressure and electrocardiogram Monitoring (24-hr ABP and ECG Monitor) (Visit 2)
  • Somatosensory evoked potentials (Visit 3, optional)
  • Transcranial Magnetic Stimulation (Visit 4, optional)
  • H-reflex (Visit 5, optional)
  • Compound Muscle Action Potentials (Peripheral nerve stimulation) (Visit 5, optional)
  • Muscle Ultrasound (Visit 5, optional)

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:

  • Arrive for testing in a fasted state (fasted for 12 hours, but they may continue to drink water)
  • Not consume caffeine, recreational drugs, alcohol, smoking, or antihypotensive drug (e.g., midodrine) for 12 hours prior to their appointment
  • No strenuous exercise within 24 hours of the start of the study. (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:

  • Cardiovascular stress test (orthostatic stress test and/or vibrostimulation or DARS)

Blood Draws:

Four (4) blood draws will be taken:

  1. At rest without tSCS
  2. At rest with tSCS
  3. During cardiovascular stress test without tSCS
  4. During cardiovascular stress test with tSCS (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:

  • Short-form (36) Health Survey (SF-36)
  • Autonomic Dysfunction following SCI (ADFSCI) questionnaire
  • Leisure Time Physical Activity Questionnaire after SCI (LTPAQ-SCI).
  • National Health Interview Survey - Chronic Conditions
  • American Thoracic Society (ATS) Adult Respiratory Disease Survey. - Tobacco Use

Cardiopulmonary Assessments:

  • Spirometry testing
  • 24-hour ABP and ECG Monitor (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:

  • Carotid and cardiac ultrasound
  • Cardiovascular stress test (orthostatic hypotension stress and/or vibrostimulation or DARS)

Blood Draws:

Four (4) blood draws will be taken:

  1. At rest without tSCS
  2. At rest with tSCS
  3. During a cardiovascular stress without tSCS
  4. During a cardiovascular stress with tSCS
Being tested
Transcutaneous Spinal Cord Stimulation (tSCS)
Keywords
Spinal Cord Stimulation, Transcutaneous Spinal Cord Stimulation, Cardiovascular dysfunction, Cardiopulmonary dysfunction, Cardiovascular Biomarkers, Endothelial cell-derived Microvesicles, Plasma Catecholamines, Autonomic Dysreflexia, Orthostatic Hypotension
Medical subject headings
Spinal Cord Injuries, Cardiovascular Diseases, Pulmonary Heart Disease, Autonomic Dysreflexia, Hypotension, Orthostatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Spinal Cord Stimulation (tSCS)Device

    Also called TESCoN device by SpineX Inc., CA, USA - experimental type II medical device, SCONE device by SpineX Inc., CA, USA - experimental type II medical 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.

Study groups in NCT06379711
Study groupRoleWhat they receive
Transcutaneous spinal cord stimulation (tSCS)ExperimentalExploring the mechanisms of SCS for improving cardiovascular function in individuals with chronic, motor-complete SCI by measuring vascular related endothelial biomarkers and plasma catecholamines
Receives: Device: Transcutaneous Spinal Cord Stimulation (tSCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (3)

  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).

    Measured: 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).

    Measured: 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pre-Post Study
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06379711
Sponsor's protocol ID
H22-03727
Status last verified
Apr 2024
First submitted
2 Apr 2024
Last updated
23 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Hubli M, Gee CM, Krassioukov AV. Refined assessment of blood pressure instability after spinal cord injury. Am J Hypertens. 2015 Feb;28(2):173-81. doi: 10.1093/ajh/hpu122. Epub 2014 Jul 1.

    PubMed 24990527

  • Forchheimer M, McAweeney M, Tate DG. Use of the SF-36 among persons with spinal cord injury. Am J Phys Med Rehabil. 2004 May;83(5):390-5. doi: 10.1097/01.phm.0000124441.78275.c9.

    PubMed 15100631

  • The National Health Interview Survey design, 1973-84, and procedures, 1975-83. Vital Health Stat 1. 1985 Aug;(18):1-127. No abstract available.

    PubMed 4082502

  • Ferris BG. Epidemiology Standardization Project (American Thoracic Society). Am Rev Respir Dis. 1978 Dec;118(6 Pt 2):1-120. No abstract available.

    PubMed 742764

  • Martin Ginis KA, Phang SH, Latimer AE, Arbour-Nicitopoulos KP. Reliability and validity tests of the leisure time physical activity questionnaire for people with spinal cord injury. Arch Phys Med Rehabil. 2012 Apr;93(4):677-82. doi: 10.1016/j.apmr.2011.11.005. Epub 2012 Feb 13.

    PubMed 22336103

  • Consortium for Spinal Cord Medicine. Early acute management in adults with spinal cord injury: a clinical practice guideline for health-care professionals. J Spinal Cord Med. 2008;31(4):403-79. doi: 10.1043/1079-0268-31.4.408. No abstract available.

    PubMed 18959359

  • Hubli M, Krassioukov AV. Ambulatory blood pressure monitoring in spinal cord injury: clinical practicability. J Neurotrauma. 2014 May 1;31(9):789-97. doi: 10.1089/neu.2013.3148. Epub 2014 Jan 30.

    PubMed 24175653

  • Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36. doi: 10.1164/ajrccm.152.3.7663792. No abstract available.

    PubMed 7663792

  • Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

    PubMed 16055882

  • Pithon KR, Martins LE, Renno AC, Abreu DC, Cliquet A Jr. Pulmonary function testing in quadriplegic subjects. Spinal Cord. 2008 Apr;46(4):275-7. doi: 10.1038/sj.sc.3102146. Epub 2007 Nov 20.

    PubMed 18026172

  • Kelley A, Garshick E, Gross ER, Lieberman SL, Tun CG, Brown R. Spirometry testing standards in spinal cord injury. Chest. 2003 Mar;123(3):725-30. doi: 10.1378/chest.123.3.725.

    PubMed 12628869

  • Park AJ, Fandl HK, Garcia VP, Coombs GB, DeSouza NM, Greiner JJ, Barak OF, Mijacika T, Dujic Z, Ainslie PN, DeSouza CA. Differential Expression of Vascular-Related MicroRNA in Circulating Endothelial Microvesicles in Adults With Spinal Cord Injury: A Pilot Study. Top Spinal Cord Inj Rehabil. 2023 Spring;29(2):34-42. doi: 10.46292/sci22-00032. Epub 2023 Apr 3.

    PubMed 37235195

  • Claydon VE, Krassioukov AV. Clinical correlates of frequency analyses of cardiovascular control after spinal cord injury. Am J Physiol Heart Circ Physiol. 2008 Feb;294(2):H668-78. doi: 10.1152/ajpheart.00869.2007. Epub 2007 Nov 16.

    PubMed 18024546

  • Aung HH, Sivakumar A, Gholami SK, Venkatewaran SP, Gorain B, Shadab M. An overview of the anatomy and physiology of the lung, in Nanotechnology-Based Targeted Drug Delivery Systems for Lung Cancer, 2019; 1-20.

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Spinal Cord Stimulation (tSCS) in people with Spinal Cord Injuries and Cardiovascular Diseases, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrea Maharaj, BSc (6046758856, amaharaj@icord.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating endothelial biomarkers in EMV/µL (Park et al., 2023) (time frame: Real-time Effect: 1 week; Long-term Effect: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06379711, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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