Acute and Chronic Repercussion of Spinal Cord Stimulation After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Valsalva Maneuver Phase II
研究概览
简要总结
The purpose of this research is to learn about how the participant's body is able to balance changes in blood pressure, and how spinal cord stimulation affects these changes as well as immune & cardiovascular function in participants with spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Spinal Injury Association Impairment Scale A-D,64 to encompass a representational spectrum of autonomic dysfunction after spinal cord injury.
- •Neurological level of injury, C6-T8, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.64 Incorporating level of injury over this broad range to capture the spectrum of autonomic dysfunction. Individuals with injuries below T8 will not be included to ensure transcutaneous spinal cord stimulation does not occur over the injury/glial scar, where it may have altered properties. The C6 level was chosen to ensure hand cold pressor stimuli triggers above level sympathetic activation.
- •Time since injury of greater than six months, given early changes in spinal cord connectivity and recovery prior to this.
- •Both individuals with and without currently implanted epidural spinal cord stimulators will be enrolled.
- •Twenty uninjured controls will also be enrolled.
排除标准
- •History of clinically diagnosed cardiovascular disease, diabetes, autonomic neuropathies, neurological disorders (with exception of spinal cord injury for individuals in those cohorts), or are active smokers.
- •Individuals who are taking betablockers, antihypertensives, or other sympathetically active medications which they are unable to hold.
- •Women who are pregnant or lactating, given known hormonal influences on autonomic regulation.65,66
- •Cognitive issues preventing informed consent for participation.
- •Body mass index >30 kg/m2 for the uninjured controls only given increased risk of prediabetes and potential confounding normative values.
- •taking or being administered a medication known to potentially have adverse interactions with phenylephrine
- •in the judgement of the principal investigator, any illness or condition that will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
研究组 & 干预措施
Control
Control participants without a spinal cord injury
干预措施: Tests of sympathetic inhibition (Diagnostic Test)
Control
Control participants without a spinal cord injury
干预措施: Testing of below level sympathetic activation (Diagnostic Test)
Epidural stimulation
Individuals with spinal cord injury receiving epidural stimulation
干预措施: Epidural stimulation (Device)
Control
Control participants without a spinal cord injury
干预措施: Tests of above level sympathetic activation (Diagnostic Test)
Transcutaneous stimulation
Individuals with spinal cord injury receiving transcutaneous stimulation
干预措施: Tests of sympathetic inhibition (Diagnostic Test)
Transcutaneous stimulation
Individuals with spinal cord injury receiving transcutaneous stimulation
干预措施: Tests of above level sympathetic activation (Diagnostic Test)
Transcutaneous stimulation
Individuals with spinal cord injury receiving transcutaneous stimulation
干预措施: Testing of below level sympathetic activation (Diagnostic Test)
Transcutaneous stimulation
Individuals with spinal cord injury receiving transcutaneous stimulation
干预措施: Transcutaneous stimulation (Device)
Epidural stimulation
Individuals with spinal cord injury receiving epidural stimulation
干预措施: Tests of sympathetic inhibition (Diagnostic Test)
Epidural stimulation
Individuals with spinal cord injury receiving epidural stimulation
干预措施: Tests of above level sympathetic activation (Diagnostic Test)
Epidural stimulation
Individuals with spinal cord injury receiving epidural stimulation
干预措施: Testing of below level sympathetic activation (Diagnostic Test)
结局指标
主要结局
Valsalva Maneuver Phase II
时间窗: During laboratory diagnostic testing session
Presence or absence of phase II on Valsalva maneuver testing, which takes approximately 15 seconds to complete. This will be repeated x3.
次要结局
- Quantify autonomic dysreflexia and orthostatic hypotension(Baseline, prior to laboratory diagnostic testing session)
- Immunology Blood Draw(During laboratory diagnostic testing session)
- Serum Catecholamines and Cortisol(During laboratory diagnostic testing session)
- Beat-to-beat heart rate(During laboratory diagnostic testing session)
- Beat-to-beat blood pressure(During laboratory diagnostic testing session)
- Continuous galvanic skin response(During laboratory diagnostic testing session)
- Beat-to-beat heart rate(During laboratory diagnostic testing session)
- Beat-to-beat blood pressure(During laboratory diagnostic testing session)
- Continuous galvanic skin response(During laboratory diagnostic testing session)
- Quantify autonomic dysreflexia and orthostatic hypotension(Baseline, prior to laboratory diagnostic testing session)
- Respiration(During laboratory diagnostic testing session)
- Beat-by-Beat Popliteal and Brachial Blood Flow(During laboratory diagnostic testing session)
- Immunology Blood Draw(During laboratory diagnostic testing session)
- Serum Catecholamines and Cortisol(During laboratory diagnostic testing session)
研究者
Ryan J. Solinsky
Principal Investigator
Mayo Clinic