Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

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.

Study Overview

• Status: Completed
• Conditions: Dysphonia
• Intervention / Treatment: Diagnostic test: surface electromyogram (sEMG); Diagnostic test: flexible laryngoscopy

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.

• Study Type: Observational
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

There will be four cohorts of subjects in the study:

• Cohort one will comprise vocally healthy controls
• Cohort two will comprise patients with Muscle Tension Dysphonia
• Cohort three will comprise patients with unilateral vocal fold paralysis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 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.; Other Names: Trigno Wireless Biofeedback System; 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.; Other Names: PENTAX Medical ENT Video Imaging System
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.	Diagnostic test: 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.; Other Names: Trigno Wireless Biofeedback System
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.	Diagnostic test: 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.; Other Names: Trigno Wireless Biofeedback System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pitch and Loudness levels in vocal tasks	Both at baseline and after a vocal loading task, muscle network activity using sEMG will be measured in a variety of vocal tasks outlined above in Table 1 to explore the muscle network across different vocal demands and pitch and loudness levels. The pitch and loudness of each task produced at baseline by each participant will be calculated, and visual feedback will be provided to participants using the Real-Time Pitch module of the Computerized Speech Lab (Pentax, Montvale, NJ) to help them reproduce similar pitch and loudness levels during post-loading recordings.	Baseline visit, 2 week visit, 2 months visit
Change in Vocal loading task	After baseline sEMG measurements, vocal fatigue will be induced using a vocal loading task of reading in the presence of 70-dB background noise, as described in Sundarrajan 51 The duration of reading that induces self-perceived vocal fatigue varies among vocally-healthy individuals.52 Therefore, we will use the CR10 Physical Exertion Scale adapted for vocal effort to have participants rate their self-perceived participant reported	Baseline visit, 2 week visit, 2 months visit
Change in Phonatory Effort (PPE)	Phonatory Effort (PPE) while reading the first section of "The Rainbow Passage" at up to four time points during the load task. The vocal loading task will end after participants report an increase of at least 2 points in PPE.	Baseline visit, 2 week visit, 2 months visit

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Aaron Johnson, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Dysphonia
• Other Study ID Numbers: 20-01770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data Upon reasonable request. Requests should be directed to achlae01@nyu.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No