CompletedNot Applicable

Ultrasound to Detect Vocal Fold Movement in Neurological Disease

United Kingdom20 participantsStarted 2022-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients who cannot be supported to demonstrate capacity to consent. * Any patient that automatically meets the clinical exclusion criteria for FNE; e.g. epistaxis risk, facial fracture, patient distress. * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 12 months

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

Timeframe: 12 months

Trial details

NCT IDNCT05493397

SponsorUniversity College, London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Neurological Disorder trials