Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

NYU Langone Health

Status: Completed

Conditions: Dysphonia

Treatments: Diagnostic Test: surface electromyogram (sEMG); Diagnostic Test: flexible laryngoscopy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04713033

20-01770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

14 participants in 3 patient groups

Vocally Healthy Controls

Description:

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.

Treatment:

Diagnostic Test: flexible laryngoscopy

Diagnostic Test: surface electromyogram (sEMG)

Muscle Tension Dysphonia Patients

Description:

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.

Treatment:

Diagnostic Test: surface electromyogram (sEMG)

Unilateral Vocal Fold Paralysis Patients

Description:

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

Treatment:

Diagnostic Test: surface electromyogram (sEMG)