Clinical trial NCT04713033: Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice
Official title: Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphonia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-01-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Change in Pitch and Loudness levels in vocal tasks
timeFrame: Baseline visit, 2 week visit, 2 months visit
measure: Change in Vocal loading task
timeFrame: Baseline visit, 2 week visit, 2 months visit
measure: Change in Phonatory Effort (PPE)
timeFrame: Baseline visit, 2 week visit, 2 months visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Aaron Johnson
role: PRINCIPAL_INVESTIGATOR
References: