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ACS: Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05650710
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
23
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase
  • Device: Nerve stimulation using nerve stimulation device and sterile wire electrode.
 N/A

Detailed Description

This is a single-arm physiology study. Consenting patients undergoing bilateral neck dissection (BND) 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 bilaterally for lymph node 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 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All patients who meet eligibility will undergo 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.All patients who meet eligibility will undergo 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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Primary Objective [Collected during a single operative procedure, taking about 15 minutes]

    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.

Secondary Outcome Measures

  1. Secondary Objective [Collected during a single operative procedure, taking about 15 minutes.]

    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.

  2. Secondary Objective [Collected during a single operative procedure, taking about 15 minutes.]

    Anatomic confirmation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, documented with photography.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult patient (≥18 years old).

  • Scheduled for 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

  • Principal Investigator: David T. Kent, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Kent, Associate Professor, Department of Otolaryngology-Head and Neck Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05650710
Other Study ID Numbers:
  • 221998
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 30, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Sleep Apnea, Obstructive

Study Results

No Results Posted as of Dec 30, 2022