Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

Head and Neck Cancer Clinical Trial

— ACS  

Official title:

Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05650710
• Other study ID #: 221998
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: Katie Hartley-Estes, RPSGT
• Phone: (615) 875-9214
• Email: katherine.e.hartley[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	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.	Collected during a single operative procedure, taking about 15 minutes
Secondary	Secondary Objective	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.	Collected during a single operative procedure, taking about 15 minutes.
Secondary	Secondary Objective	Anatomic confirmation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, documented with photography.	Collected during a single operative procedure, taking about 15 minutes.