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临床试验/NCT05556902
NCT05556902招募中不适用

Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Arterial Blood Pressure Change

研究概览

简要总结

The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).

详细描述

The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).

The Investigators will identify patients with chronic pain who are scheduled for SCS implant at the University of Alabama at Birmingham for management of chronic neuropathic pain as part of routine care. The research team will assess BP with an arm cuff arm cuff before and after the implant among patients providing written informed consent.

The Investigators' central clinical hypothesis is that SCS decreases blood pressure in patients with chronic pain and comorbid hypertension. The Investigators further hypothesize that the SCS will improve serological markers of sympathetic nerve activity and kidney function, possibly due to reductions in spinal cord sympathetic nerve activity. A secondary hypothesis is that higher baseline blood pressure predicts larger reductions in blood pressure following SCS implant.

Additionally, this project seeks to expand knowledge on therapeutic mechanisms of SCS via recording electrophysiological responses at the spinal cord (via adjacent, unused SCS contacts) and from EEG scalp recordings over the cerebral cortex.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or Female, age 18-89
  • •Chronic pain for more than 3 months
  • •Willing to visit a research lab
  • •Willing to undergo a blood draw
  • •Able to provide written informed consent

排除标准

  • •History of neurological disease (e.g., dementias, Parkinson's)
  • •History of stroke
  • •Current diagnosis of cancer
  • •Subject is unwilling or unable to comply with the protocol

研究组 & 干预措施

Treatment

Experimental

Patients that proceed with permanent implantation of a spinal cord stimulator.

干预措施: Permanent Epidural Spinal Cord Stimulation (Device)

Control

No Intervention

Patients who do not proceed with permanent implantation of a spinal cord stimulator.

结局指标

主要结局

Arterial Blood Pressure Change

时间窗: Visit 2 (4-6 weeks post-op)

The research team will assess systolic and diastolic blood pressure with an arm cuff.

Arterial Blood Pressure Change

时间窗: Baseline (1 week pre-op)

The research team will assess systolic and diastolic blood pressure with an arm cuff.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marshall Holland

Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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