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

NCT06379711 | Not Yet Recruiting

• 1 other identifier: H22-03727
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 parameters.

Conditions

Spinal Cord Injuries; Cardiovascular Diseases; Cardiopulmonary Diseases

Keywords

Spinal Cord Stimulation; Transcutaneous Spinal Cord Stimulation; Cardiovascular dysfunction; Cardiopulmonary dysfunction; Cardiovascular Biomarkers; Endothelial cell-derived Microvesicles; Plasma Catecholamines; Autonomic Dysreflexia; Orthostatic Hypotension

Outcome Measures

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).

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

Secondary Outcomes (3)

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

  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: 1 week; Long-term Effect: 8 weeks

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

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

Study Arms (1)

Transcutaneous spinal cord stimulation (tSCS)

EXPERIMENTAL

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)

Interventions

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.

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

Transcutaneous spinal cord stimulation (tSCS)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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:
• Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.
• 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.
• A participant who meets any of the following criteria will not be eligible to participate:
• Ventilator dependent.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Blusson Spinal Cord Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (14)

• 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.

  PMID: 24990527 BACKGROUND

• 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.

  PMID: 15100631 BACKGROUND

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

  PMID: 4082502 BACKGROUND

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

  PMID: 742764 BACKGROUND

• 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.

  PMID: 22336103 BACKGROUND

• 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.

  PMID: 18959359 BACKGROUND

• 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.

  PMID: 24175653 BACKGROUND

• 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.

  PMID: 7663792 BACKGROUND

• 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.

  PMID: 16055882 BACKGROUND

• 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.

  PMID: 18026172 BACKGROUND

• 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.

  PMID: 12628869 BACKGROUND

• 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.

  PMID: 37235195 BACKGROUND

• 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.

  PMID: 18024546 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Cardiovascular Diseases; Pulmonary Heart Disease; Autonomic Dysreflexia; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Heart Diseases; Autonomic Nervous System Diseases; Orthostatic Intolerance; Primary Dysautonomias; Hypotension; Vascular Diseases

Study Officials

• Andrei Krassioukov, MD,PhD,FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Maharaj, BSc

CONTACT

6046758856; amaharaj@icord.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-Post Study

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 23, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available upon full-text print publication in a peer-reviewed journal, for a duration of at least 10 years.
• Access Criteria: Online access or e-mail request to the corresponding author from an established scientific investigator.

Locations

CA (1)