Investigation of Human Laryngeal Evoked Brainstem Potentials

NYU Langone Health

Status: Completed

Conditions: Thyroidectomy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02803359

05-414

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Planned Procedure

Experimental group

Description:

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.

Treatment:

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

Routine Laryngoscopy

Experimental group

Description:

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

Treatment:

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