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Completed

NCT Number: NCT05650710

Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

Recently published data suggest that stimulation of the infrahyoid strap muscles increases pharyngeal patency in patients with obstructive sleep apnea, but the innervation of these muscles by the ansa cervicalis is variable. The investigators propose a study examining the anatomic variation of the ansa cervicalis and the effect of neurostimulation on muscle recruitment.

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Key information

Conditions

Head and Neck Cancer Apnea Dyssomnias Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

This is a single-arm physiology study. Consenting patients undergoing neck dissection (ND) for cervical lymphadenectomy of level IV will undergo dissection of the ansa cervicalis nerves to the infrahyoid strap muscles. Per routine care, a large incision is made across the neck to provide surgeons access to the cervical lymph nodes for extirpation. During this dissection, the branch(es) of the ansa cervicalis nerve plexus descending from the loop of the plexus and innervating the infrahyoid strap muscles (the "common trunk") are dissected uni- or bilaterally. For this study, measurements and photos/videos of the common trunks will be taken. An electrode will be placed on one or both common trunks to stimulate infrahyoid muscles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (≥18 years old).
  • Scheduled for uni- or bilateral neck dissection (BND) for cervical lymphadenectomy of level IV and other indicated procedures for management of head and neck cancer.

Exclusion criteria

  • Unable to consent for research due to a pre-existing neurologic condition as determined by PI.
  • Unable to consent for research due to language barriers.
  • History of prior neck surgery with transection of the infrahyoid strap muscles as determined by clinical history.

Treatment and study plan

Nerve stimulation using nerve stimulation device and sterile wire electrode.

Device

A nerve stimulator device will be used in this study as a research tool to investigate whether a future (currently nonexistent) medical device might be able to stimulate desired infrahyoid musculature in a therapeutic manner.

Primary outcomes

  1. Primary Objective

    Time frame: Collected during a single operative procedure, taking about 15 minutes

    Anatomic measurements of the length, diameter, and comformation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, measured in mm with a flexible ruler.

Secondary outcomes

  1. Secondary Objective

    Time frame: Collected during a single operative procedure, taking about 15 minutes.

    The amount of caudal movement of the thyroid cartilage and hyoid bone with stimulation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, measured in mm with a flexible ruler.

  2. Secondary Objective

    Time frame: Collected during a single operative procedure, taking about 15 minutes.

    Anatomic confirmation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, documented with photography.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus

Acronym: ACS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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