Contribution of Functional MRI in Assessment of Auditory Processing Disorders (NCT03887182) | Clinical Trial Compass
CompletedNot Applicable
Contribution of Functional MRI in Assessment of Auditory Processing Disorders
France45 participantsStarted 2020-09-02
Plain-language summary
Auditory Processing Disorder (APD) affects 0.5-7% of the pediatric population. This disorder is responsible for a child's low hearing ability. The diagnosis of APD is difficult because of polymorphic symptoms possibly entangled with other difficulties (learning, communication, attention ...). There is currently no gold standard in the literature for diagnosing APD. Investigators opened multidisciplinary consultation for the children suspected of APD. The purpose of this study is to analyze the results of the multidisciplinary assessment performed on these children (audiometry, cortical auditory brainstem response (ABR), behavioral assessment, psychometric evaluation, genetic analysis) to the results of functional MRI (fMRI) at rest and in activation. The goal is to find radiological MRI-fMRI markers in these patients that improve the diagnosis of APD.
Investigators will compare the f-MRI results between three groups of children in order to find specific radiological markers of APD :
* group 1 : children diagnosed with an Auditory Processing Disorder (APD)
* group 2 : children suspect of APD
* group 3 : children without APD (controls)
Who can participate
Age range
7 Years – 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 Group 1 \& 2: :
* 7 to 18 years old
* selected following multidisciplinary consultation whether the diagnosis is confirmed (group G1) or not (group G2).
* Signed consent of both parents
* Affiliated with a health insurance plan
Inclusion Criteria Group 3:
* 7 to 18 years old
* do not present any known hearing pathology
* Signed consent of both parents
* Affiliated with a health insurance plan
Exclusion Criteria:
* Require general anesthesia for MRI
* Contraindication to MRI
* Hearing aids for more than three months prior to inclusion in the study
* Require sedation specifically for research
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.