Ultrasound to Detect Vocal Fold Movement in Neurological Disease

NCT05493397 | Completed

• 1 other identifier: 146531
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the accuracy and viability of transcutaneous laryngeal ultrasound (US) in detecting impairments of vocal fold movement in people with neurological disorders. The accuracy and viability of laryngeal US compared with reference standard fibreoptic nasendoscopic examination (FNE) will be evaluated. The study also includes measurements of clinician reliability in US image acquisition and interpretation, and assess the acceptability of US assessment to people with neurological disorders. Data will be used to assess the ability of US to detect other laryngeal pathology, and to calculate the sample size required for a validation study.

Conditions

Neurological Disorder; Ultrasound; Vocal Fold Movement

Outcome Measures

Primary Outcomes (2)

• Accuracy of transcutaneous laryngeal US in the diagnosis of vocal fold movement impairment in patients with neurological disease.

  Each participant with be assessed using i) laryngeal ultrasound (US) and ii) fibreoptic nasendoscopic examination (FNE). One ENT or SLT will pass an FNE to assess vocal fold function. Images will be interpreted by an ENT consultant blinded to the outcomes of the laryngeal US. Two blinded SLTs will capture and interpret laryngeal US images. Each SLT will be blinded to the outcomes of i) the FNE assessment and ii) their SLT peer US assessment. Vocal fold movement will be assessed using a three-point scale (0 - normal movement, 1- impaired movement, 2- no movement). Descriptive and inferential statistics will be used to establish the sensitivity and specificity of laryngeal US in detecting an impairment of vocal fold movement impairment. A consensus agreement between the two blinded SLTs will be used to calculate the sensitivity and specificity.

  12 months

• Technical and environmental viability of laryngeal US in patients with neurological disease.

  Image acquisition scored on a binary scale (possible/not possible). Any technical or environmental factors preventing US image acquisition will be captured on a pre-determined spread sheet.

  12 months

Secondary Outcomes (4)

• Reliability of assessors in capturing and interpreting laryngeal US images for the purpose of vocal fold movement assessment in patients with neurological disease.

  15 months

• Acceptability of transcutaneous laryngeal US to patients with neurological disease.

  15 months

• Diagnostic accuracy and feasibility of laryngeal US between patients of different neurological disease groups

  15 months

• Ability of US to detect other laryngeal pathology in patients with neurological disease.

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with neurological impairment due to be referred to Ear, Nose and Throat (ENT)services with suspected impairment of vocal fold function.

You may qualify if:

• Patients under in-patient our out-patient Speech and Language Therapy care at primary study site.
• Patients with a neurological condition who have a suspected impairment of vocal fold movement due to diagnosis of dysphonia, breathing difficulties and/or impaired cough as determined by their lead Speech and Language Therapist.
• Over 18 years old
• Has undergone/will undergo nasendoscopy as part of their standard clinical care.

You may not qualify if:

• Patients who cannot be supported to demonstrate capacity to consent.
• Patients who do not have sufficient command of English to consent in this study will also be excluded from the study due to limited resources for advocacy services. Participants will require sufficient English language skills to participate in the patient questionnaire.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals

London, WC1N 3BG, United Kingdom

Location

Related Publications (3)

• Bolton L, Mills C, Wallace S, Brady MC; Royal College of Speech and Language Therapists (RCSLT) COVID-19 Advisory Group. Aerosol generating procedures, dysphagia assessment and COVID-19: A rapid review. Int J Lang Commun Disord. 2020 Jul;55(4):629-636. doi: 10.1111/1460-6984.12544. Epub 2020 Jun 1. No abstract available.

  PMID: 32478950 BACKGROUND

• Allen J, Clunie G, Slinger C et al. Utility of ultrasound in the assessment of swallowing and laryngeal function: A rapid review and critical appraisal of the literature. International Journal of Language and Communication Disorders 2021 56 (1): 174-204.

  BACKGROUND

• Langmore SE. Endoscopic Evaluation and Treatment of Swallowing Disorders. 2001. New York: Thieme Publishers

  BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Jodi Allen

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: August 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

GB (1)