Investigation of Human Laryngeal Evoked Brainstem Potentials

NCT ID: NCT02803359

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-07-28

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.

Conditions

Thyroidectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Planned Procedure

Endoscope will be connected to a camera and monitor. Needle electrodes will then be positioned into the false vocal fold mucosa bilaterally, under direct visualization of the needle tip on the monitor, but the needles will be passed trans-orally in the operating room. For those participating during an open-neck surgery, the surgery will commence as planned and once exposure of the superior laryngeal nerve is obtained, the surgeon will insert the electrodes directly into the nerve trunk for the purposes of recording. In Surgery or cervical lymphadenectomy, the electrode will be placed at a superficial depth and needle placement will be performed with one on each side at a location approximately mid-fold.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Routine Laryngoscopy

Nasolaryngoscopy will be performed in the office in the standard fashion with the use of oxymetazoline for topical decongestion of the nasal mucosa, In both settings, the electrode will be placed at a superficial depth and needle placement will be performed with one on each side at a location approximately mid-fold

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Interventions

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

Intervention Type: PROCEDURE

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)
• Laryngopharyngeal Reflux Disease
• Allergy to Lidocaine
• Allergy to Oxymetazoline

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milan Amin, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

05-414

Identifier Type: -

Identifier Source: org_study_id