Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation (ACS)

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Head and Neck Cancer; Obstructive Sleep Apnea

Treatments: Device: Nerve stimulation using nerve stimulation device and sterile wire electrode.

Study type: Interventional

Funder types: Other

Identifiers

NCT05650710

221998

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Surgical Procedure

Other group

Description:

Consented patients who meet eligibility will have a surgical procedure for management of head and neck cancer, with dissection and exposure of the relevant anatomic structures as part of regular clinical care.

Treatment:

Device: Nerve stimulation using nerve stimulation device and sterile wire electrode.