Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

Not Applicable

Completed

• Conditions: Dysphonia
• Interventions: Diagnostic Test: surface electromyogram (sEMG); Diagnostic Test: flexible laryngoscopy

• Registration Number: NCT04713033
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Study Start: 2021-09-09
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experiment 1	surface electromyogram (sEMG)	Experiment 1 (Aim 1) will utilize a 16-channel sEMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Flexible laryngoscopy will be performed to exclude any existing pathology and confirm eligibility in the healthy control group. 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.
Experiment 3	surface electromyogram (sEMG)	In Experiment 3 (Aim 2), the study will measure patients with unilateral vocal old paralysis, representing a neurologically impaired network, before and after a vocal fold medialization procedure.
Experiment 1	flexible laryngoscopy	Experiment 1 (Aim 1) will utilize a 16-channel sEMG array to characterize cervical-cranial muscle activity networks in typical speakers at baseline and after a vocal loading task. Flexible laryngoscopy will be performed to exclude any existing pathology and confirm eligibility in the healthy control group. 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.
Experiment 2	surface electromyogram (sEMG)	In Experiment 2 (Aim 2), the study 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 but potentially maladaptive network.

Primary Outcome Measures

Name	Time	Method
Change in Pitch and Loudness levels in vocal tasks	Baseline visit, 2 week visit, 2 months visit	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.
Change in Vocal loading task	Baseline visit, 2 week visit, 2 months visit	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
Change in Phonatory Effort (PPE)	Baseline visit, 2 week visit, 2 months visit	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States