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OpenTrials
Completed

NCT Number: NCT02264262

Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers

Activation of the sympathetic nervous system is associated with increased risk of ventricular arrhythmias and sudden cardiac death (SCD). Development of simple, noninvasive, reliable tools to measure sympathetic outflow in human subjects is therefore highly desirable.

Microneurography is the current gold standard measurement technique, whereby multiunit postganglionic sympathetic nerve activity is recorded with tungsten ultrafine microelectrodes inserted selectively into nerve fascicles of the peroneal nerve. Though this technique is considered extremely safe, and has been used successfully for decades in human translational physiology experiments, it has not been adopted for routine clinical assessment due to the requirement for sophisticated equipment and specific technical training and skills. Alternatively, many have adopted heart rate variability as a simple, noninvasive technique for assessing sympathetic nerve activity. However, heart rate variability does not directly measure sympathetic nerve activity, and there is much debate in the literature as to the exact source of sympathetic nerve traffic. For example, many believe it is an accurate reflection of cardiac sympathetic nerve activity, but does not accurately reflect changes in muscle or skin sympathetic nerve activity.

To address these limitations, the investigators have developed a simple, noninvasive technique to measure sympathetic nerve activity using surface electrodes.

Despite its great promise, this new approach has not yet been directly validated. The purpose of this study is therefore to validate this new technique (refered to as EKG-NA) against the current gold standard measurement technique, microneurography.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-45 years of age
  • BMI < 35 kg/m2

Exclusion criteria

  • History of hypertension, diabetes, pulmonary disease, metabolic disease or heart failure
  • Cardiac rhythm disorder, specifically: rhythm other than sinus
  • Use of any medications other than common supplements
  • Unable to perform handgrip exercise
  • Pregnant

Treatment and study plan

Physiologic maneuvers

Other

Subjects will perform cold pressor test, valsalva maneuver, hand grip and post-exercise occlusion in a controlled research environment

Primary outcomes

  1. Chane in Sympathetic nerve activity

    Time frame: Change from baseline in sympathetic nerve activity at 2 hours

    Multi-unit recordings of sympathetic nerve activity will be obtained with single-use sterile tungsten microelectrodes inserted selectively into muscle or skin nerve fascicles of the peritoneal nerve and EKG-NA by standard surface electrodes

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2014
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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