Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 65 years old?
Source: NCT06379711, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of British Columbia
- Trial code
- NCT06379711
- Record updated
- 23 April 2024
- Original description
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 full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: 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; Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk; Participant has undergone electrode implantation surgery; Painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing; 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.); Severe anemia (Hgb<8 g/dl) or hypovolemia as measured by hematocrit via blood test in the last six months; A participant who meets any of the following criteria will not be eligible to participate:; Ventilator dependent; Intrathecal baclofen pump; Participant is a member of the investigational team or his/her immediate family.
INCLUSION \& EXCLUSION CRITERIA:.