Clinical trial NCT05650710: Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation
Official title: Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Obstructive Sleep Apnea
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: BASIC_SCIENCE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Primary Objective
timeFrame: Collected during a single operative procedure, taking about 15 minutes
Secondary outcomes:
measure: Secondary Objective
timeFrame: Collected during a single operative procedure, taking about 15 minutes.
measure: Secondary Objective
timeFrame: Collected during a single operative procedure, taking about 15 minutes.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David T. Kent, MD
role: PRINCIPAL_INVESTIGATOR
References: