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Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation (ACS)

Primary Purpose

Head and Neck Cancer, Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nerve stimulation using nerve stimulation device and sterile wire electrode.
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgical Procedure

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2022
Last Updated
August 21, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05650710
Brief Title
Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation
Acronym
ACS
Official Title
Intraoperative Identification and Stimulation of the Ansa Cervicalis Nerve Plexus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Procedure
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Nerve stimulation using nerve stimulation device and sterile wire electrode.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Objective
Description
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.
Time Frame
Collected during a single operative procedure, taking about 15 minutes
Secondary Outcome Measure Information:
Title
Secondary Objective
Description
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.
Time Frame
Collected during a single operative procedure, taking about 15 minutes.
Title
Secondary Objective
Description
Anatomic confirmation of the common trunk of the ansa cervicalis to the sternothyroid muscle and it's dependent branches, documented with photography.
Time Frame
Collected during a single operative procedure, taking about 15 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Hartley-Estes, RPSGT
Phone
(615) 875-9214
Email
katherine.e.hartley@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Von Wahlde, MJ, CCRP
Phone
(615) 322-0333
Email
kate.vonwahlde@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T. Kent, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Hartley-Estes, RPSGT
Phone
615-875-9214
Email
katherine.e.hartley@vumc.org
First Name & Middle Initial & Last Name & Degree
Kate Von Wahlde, MJ,CCRP
Phone
(615) 322-0333
Email
kate.vonwahlde@vumc.org
First Name & Middle Initial & Last Name & Degree
David T Kent, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraoperative Ansa Cervicalis Nerve (ACN) Stimulation

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