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NCT05650710 | RECRUITING | Head and Neck Cancer

Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation
Sponsor:

Vanderbilt University Medical Center

Information provided by (Responsible Party):

David Kent

Brief Summary:

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.

Condition or disease

Head and Neck Cancer

Obstructive Sleep Apnea

Intervention/treatment

Nerve stimulation using nerve stimulation device and sterile wire electrode.

Phase

NA

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus
Actual Study Start Date : 2023-02-28
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

Location Details

NCT05650710

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Locations

RECRUITING

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232