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Clinical Trials/NCT02803359
NCT02803359
Completed
Not Applicable

Investigation of Human Laryngeal Evoked Brainstem Potentials

NYU Langone Health1 site in 1 country14 target enrollmentJune 2016
ConditionsThyroidectomy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroidectomy
Sponsor
NYU Langone Health
Enrollment
14
Locations
1
Primary Endpoint
analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodes
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
July 28, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

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.

Study Sites (1)

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