Investigation of Human Laryngeal Evoked Brainstem Potentials

The primary purpose of this study will be to determine whether the proposed study protocol will allow for reliable detection of the human Laryngeal evoked brainstem responses (LEBR). Laryngeal evoked brain stem responses will be recorded from five test subjects under general anesthesia in the operating room with the assistance of an electrophysiologist with expertise in evoked potentials. Once the feasibility of obtaining tracings are established on the first few subjects, responses will be recorded from other test subjects with the aim of determining the optimal placement of stimulating electrodes and detection leads necessary to elicit an adequate response. The effect of varying the stimulus intensity will also be studied. Once parameters for testing have been standardized, normative configurations for the laryngeal evoked brainstem response tracings can be determined by patients both in the office setting and in the operating room.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroidectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Healthy Subjects undergoing thyroid or other open neck surgeries

Exclusion criteria

Current or recent (within one month) tracheostomy
Vocal cord paralysis
History of Stroke
History of Diabetes Mellitus
History of Neurologic Disease
History of Radiation to the Neck
History of Brain Surgery
History of Neck Surgery
Recent Laryngeal Surgery (within one month)
Recent Intubation (within two weeks)
Laryngopharyngeal Reflux Disease
Allergy to Lidocaine
Allergy to Oxymetazoline

Treatment and study plan

Placement of a needle electrode through the thyrohyoid membrane into the submucosal space within the false vocal fold

Procedure

Primary outcomes

analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodes

Time frame: One Year

Distributions of latencies within this group will be examined to evaluate the appropriateness of standard assumptions regarding normality and constant variance, and transformations or non-parametric statistics will be considered as needed.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Jun 17, 2016
Registry last updated: Aug 25, 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.

Published trials that share one or more normalized conditions with this study.

Completed