Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Circulating endothelial biomarkers in EMV/µL (Park et al., 2023)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION &
排除标准
- •INCLUSION CRITERIA:
- •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 CRITERIA:
- •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.
- •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.
研究组 & 干预措施
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
干预措施: Transcutaneous Spinal Cord Stimulation (tSCS) (Device)
结局指标
主要结局
Circulating endothelial biomarkers in EMV/µL (Park et al., 2023)
时间窗: Real-time Effect: 1 week; Long-term Effect: 8 weeks
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).
次要结局
- 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)
- Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008)(Real-time Effect: 1 week; Long-term Effect: 8 weeks)
研究者
Andrei Krassioukov
Principal Investigator
University of British Columbia