Transcutaneous Spinal Neuromodulation to Normalize Autonomic Phenotypes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Valsalva Maneuver Phase II
研究概览
简要总结
This study looks to characterize autonomic nervous system dysfunction after spinal cord injury and identify the potential role that transcutaneous spinal cord stimulation may play at altering neuroregulation. The autonomic nervous system plays key parts in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically encounter complications. For both individuals with spinal cord injury and uninjured controls, experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate sympathetic signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. In both study populations, transcutaneous spinal cord stimulation will be added, testing previously advocated parameters to alter autonomic neuroregulation. In accomplishing this, the investigators hope to give important insights to how the autonomic nervous system works after spinal cord injury and if it's function can be improved utilizing neuromodulation.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants
- •- age 18-30 years old.
- •Participants with spinal cord injury
- •Adult onset, traumatic spinal cord injury.
- •Time since injury 1 year, in an effort to limit baroreflex desensitization.
- •American Spinal Injury Association Impairment Scale, A, to limit potential confounders.
- •Neurological level of injury, T1-T6, as defined by the International Standards for Neurological Classification of Spinal Cord Injury.
排除标准
- •History of cardiovascular disease, hypertension, neurologic disorders (with exception of spinal cord injury), or diabetes.
- •Women who are pregnant or lactating.
- •Currently taking blood thinners.
- •Taking anti-hypertensive or other medication that could influence any of the dependent autonomic variables.
结局指标
主要结局
Valsalva Maneuver Phase II
时间窗: Through study completion, average 3 months
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
- Beat-to-beat blood pressure(Through study completion, average 3 months)
- Quantify autonomic dysreflexia and orthostatic hypotension(Baseline, prior to initial laboratory diagnostic testing session)
- Muscle sympathetic nerve activity(Through study completion, average 3 months)
- Continuous galvanic skin response(Through study completion, average 3 months)
- Beat-to-beat heart rate(Through study completion, average 3 months)
- Quantify secondary autonomic complications(Baseline, prior to initial laboratory diagnostic testing session)
研究者
Ryan Solinsky
Clinician-Investigator
Spaulding Rehabilitation Hospital