CompletedNot Applicable

Early UVFP Management Based on Neurological Evidences (ION-UVFP) - Preliminary Study

Belgium40 participantsStarted 2019-06-15

Plain-language summary

The purpose of this preliminary study is to help clarify our hypotheses for the longitudinal study by investigating the relationship between vocal cord paralysis and central auditory processes and thus the interpretation of auditory inputs into the central nervous system.

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: * Unilateral paralysis in abduction of the vocal cords may be included in the study. * Patients who undergone type I thyroplasty (with Montgomery implant) at least 3 months ago * Control participants without voice disorder Exclusion Criteria: * Wear a pacemaker or other implanted devices (prostheses ...). * Wear metal clips, metal in the head, or an adjustable brain drain. * Wear non-removable dental appliances (except fillings). * Wear cardiac valve prostheses. * Have worked the metals. * Have a tattoo containing metal particles. * Have implanted jewelry (e.g., piercing). * Being prone to epileptic seizures. * Take medications that alter cortical excitability. * Have had a brain surgery. * Suffer from intracranial hypertension. * Be pregnant or breastfeeding recently. * Present allergies that are incompatible with the experimental protocol. * Have an abnormal hearing loss in view of their age, identified with tonal and / or vocal audiometry.

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

Voice quality

Timeframe: Min 3 months post thyroplasty

Changes in the neuronal pathways involved in the processing of the auditory inputs

Timeframe: Max 6 months after involvement in the study

Central auditory processes

Timeframe: Min 3 months post thyroplasty

Trial details

NCT IDNCT03966183

SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Unilateral Vocal Cord Paralysis trials

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.