Status:

COMPLETED

Computational Cranial and Cervical Muscle Network in Normal and Disordered Voice

Lead Sponsor:

NYU Langone Health

Collaborating Sponsors:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Conditions:

Dysphonia

Eligibility:

All Genders

18-88 years

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 objectiv...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 9 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 25 2022

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT04713033

Start Date

September 9 2021

End Date

May 25 2022

Last Update

May 1 2025

Active Locations (1)

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NYU Langone Health

New York, New York, United States, 10016