Noninvasive Measurement of Sympathetic Nerve Activity in Healthy Volunteers

NCT02264262 | Completed

• 1 other identifier: PRO00036916
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sympathetic Nerve Activity

Outcome Measures

Primary Outcomes (1)

• Chane in Sympathetic nerve activity

  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

  Change from baseline in sympathetic nerve activity at 2 hours

Study Arms (1)

Sympathetic nerve activity

EXPERIMENTAL

Healthy volunteers will undergo microneurography, and non invasive sympathetic nerve activity by EKG analysis at baseline and in response to stress.

Other: Physiologic maneuvers

Interventions

Physiologic maneuvers OTHER

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

Sympathetic nerve activity

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Study Officials

• Ronald Victor, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 14, 2020

Record last verified: 2017-08

Locations

US (1)