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Investigation of Human Laryngeal Evoked Brainstem Potentials

Investigation of Human Laryngeal Evoked Brainstem Potentials

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02803359
Enrollment
14
Registered
2016-06-17
Start date
2016-06-30
Completion date
2020-07-28
Last updated
2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy

Keywords

Laryngeal evoked brainstem response (LEBR), laryngopharyngeal sensory discrimination testing (LPSDT), brainstem activity

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.

Interventions

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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodesOne YearDistributions 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026