Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

Dysphonia Clinical Trial

Official title:

Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04713033
• Other study ID #: 20-01770
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysphonia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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