Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

NCT ID: NCT04713033

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-05-25

Brief Summary

The long-term goal is to transform the diagnosis and treatment of dysphonia by elucidating cervical and cranial neuromuscular mechanisms underlying typical and disordered voicing. The overall objective of this application is to propose and evaluate a novel objective spectrotemporal diagnostic tool measuring functional cervical-cranial muscle network activity in typical and disordered speakers.The purpose of this study is to improve our understanding of how the vocal tract and the muscles of the larynx and the head work at baseline and after vocal fatigue.

Detailed Description

Three experiments will be conducted over the 2-year award period. Experiment 1 (Aim 1) will utilize a 16-channel EMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Aim 2 will quantify how cervical muscle networks are perturbed in patients with two different types of dysphonia and examine if standard-of-care treatment restores cervical-cranial muscle networks to more typical states. In Experiment 2 (Aim 2), we will measure muscle networks in patients with muscle tension dysphonia before and after a course of voice therapy. Patients with muscle tension dysphonia represent an intact butpotentially maladaptive network. In Experiment 3 (Aim 2), we will measure patients with unilateral vocal fold paralysis, representing a neurologically impaired network, before and after a vocal fold injection medialization procedure.

Conditions

Dysphonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vocally Healthy Controls

Patients will undergo a single experiment to quantify cervical-cranial muscle network patterns during vocal tasks at baseline and after a vocally fatiguing vocal loading task (loud reading) and typical swallowing task.

surface electromyogram (sEMG)

Intervention Type: DIAGNOSTIC_TEST

A device that measures electrical signals from your skin will be connected to those stickers and will make a graph that is characteristic to your vocal function.

flexible laryngoscopy

Intervention Type: DIAGNOSTIC_TEST

A device that examines the throat and nasal passages. The flexible laryngoscope or "scope" consists of an eyepiece and a fiber-optic light enclosed in a thin, flexible tube. The scope looks like a strand of black spaghetti with a tiny light on the end of it. The scope is inserted through the nose, and can be moved around to help the doctor see all areas of the nasal passages and throat.

Muscle Tension Dysphonia Patients

Patients with muscle tension dysphonia will be measured at baseline and approximately 2 months after their baseline visit following a standard course of voice therapy.

surface electromyogram (sEMG)

Intervention Type: DIAGNOSTIC_TEST

A device that measures electrical signals from your skin will be connected to those stickers and will make a graph that is characteristic to your vocal function.

Unilateral Vocal Fold Paralysis Patients

Patients with unilateral vocal fold paralysis will be measured at baseline approximately 2 weeks after receiving a vocal fold medialization injection.

surface electromyogram (sEMG)

Intervention Type: DIAGNOSTIC_TEST

A device that measures electrical signals from your skin will be connected to those stickers and will make a graph that is characteristic to your vocal function.

Interventions

surface electromyogram (sEMG)

A device that measures electrical signals from your skin will be connected to those stickers and will make a graph that is characteristic to your vocal function.

Intervention Type: DIAGNOSTIC_TEST

flexible laryngoscopy

A device that examines the throat and nasal passages. The flexible laryngoscope or "scope" consists of an eyepiece and a fiber-optic light enclosed in a thin, flexible tube. The scope looks like a strand of black spaghetti with a tiny light on the end of it. The scope is inserted through the nose, and can be moved around to help the doctor see all areas of the nasal passages and throat.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Trigno Wireless Biofeedback System; PENTAX Medical ENT Video Imaging System

Eligibility Criteria

Inclusion Criteria

Experimental Group

• Age >18 years;
• Patient cohorts diagnosed with muscle tension dysphonia with a recommended treatment of voice therapy.
• Patient cohorts diagnosed with unilateral vocal cord paralysis with a recommended treatment of vocal fold injection medialization.
• Willingness to complete all clinical/research assessments
• Ability to give informed consent

(Control Group)

• Age >18 years;
• Absence of any organic vocal lesion as determined on flexible laryngoscopy.
• Willingness to complete all clinical/research assessments
• Ability to give informed consent

Exclusion Criteria

Experimental Group:

• Any contraindication for wearing the device, such as a known or reported (at any time including during the study):
• allergy;
• history of head and neck surgery in the past 3 months;
• presence of open wound or/and ulcer in close proximity to sEMG sensors;
• 'smart' implant with a microcontroller (such as a pain pump or nerve stimulator);
• participation in additional clinical research studies using investigational treatments.

Control group:

• Any contraindication for wearing the device, such as a known or reported (at any time including during the study) allergy;
• Abnormal laryngeal structure and function as determined via laryngeal endoscopic exam;
• History of head and neck surgery in the past 3 months;
• Presence of open wound or/and ulcer in close proximity to sEMG sensors;
• 'Smart' implant with a microcontroller (such as a pain pump or nerve stimulator);
• Participation in additional clinical research studies using investigational treatments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 88 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Johnson

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

20-01770

Identifier Type: -

Identifier Source: org_study_id