Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury
NCT ID: NCT06379711
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
22 participants
INTERVENTIONAL
2024-08-01
2028-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acute Cardiac Responses to Spinal Cord Injury
NCT03143179
Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
NCT05369520
Spinal Cord Stimulation for Respiratory Rehabilitation in Patients With Chronic Spinal Cord Injury
NCT06019949
Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
NCT06841198
Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
NCT07210411
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
(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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Transcutaneous spinal cord stimulation (tSCS)
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Resident of British Columbia, Canada with active provincial medical services plan
2. Male or female, 19-65 years of age
3. Chronic SCI at or above the T10 spinal cord segment
4. \>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
5. American Spinal Injury Association Impairment Scale (AIS) A, B, C and D for SCI
6. Stable management of spinal cord related clinical issues (e.g., spasticity management)
7. 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.
8. 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.
9. Must provide informed consent.
10. 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).
11. Willing and able to comply with all clinic visits and study-related procedures.
Exclusion Criteria
1. Ventilator dependent.
2. Painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing
3. Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
4. 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.
5. Intrathecal baclofen pump.
6. Cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
7. 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.).
8. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
9. Severe anemia (Hgb\<8 g/dl) or hypovolemia as measured by hematocrit via blood test in the last six months.
10. Participant has undergone electrode implantation surgery.
11. Participant is a member of the investigational team or his/her immediate family.
19 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrei Krassioukov
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrei Krassioukov, MD,PhD,FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
The National Health Interview Survey design, 1973-84, and procedures, 1975-83. Vital Health Stat 1. 1985 Aug;(18):1-127. No abstract available.
Ferris BG. Epidemiology Standardization Project (American Thoracic Society). Am Rev Respir Dis. 1978 Dec;118(6 Pt 2):1-120. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H22-03727
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.