Investigation of Human Laryngeal Evoked Brainstem Potentials

Thyroidectomy Clinical Trial

Official title:

Investigation of Human Laryngeal Evoked Brainstem Potentials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803359
• Other study ID #: 05-414
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 28, 2020

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analysis of variance in brain auditory evoked response (BAER) measured using recording electroencephalography electrodes	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.	One Year