Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-28

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Head and Neck Cancer Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients who meet eligibility will undergo uni- or bilateral neck dissection and other indicated procedures for management of head and neck cancer and will have measurements and photos/videos of the common trunks taken. An electrode will be placed on one or both common trunks to stimulate infrahyoid muscles.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Surgical Procedure

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.

Group Type OTHER

Nerve stimulation using nerve stimulation device and sterile wire electrode.

Intervention Type 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.

Interventions

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Nerve stimulation using nerve stimulation device and sterile wire electrode.

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No