Vestibular Cochlear Implant Hearing Impaired Child
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|ClinicalTrials.gov Identifier: NCT03599804|
Recruitment Status : Not yet recruiting
First Posted : July 25, 2018
Last Update Posted : July 25, 2018
|Condition or disease|
The structural and functional integrity of the vestibular system is necessary for maintenance of the complex postural system and adaptation to the environment. The absence of vestibular function is accompanied by poor prognosis and severe limitations in the activities of daily life, such as ambulating in low-light environments or on uneven ground, swimming, driving fast, etc.
The exact mechanisms responsible for the postoperative vestibular changes and/or symptoms, but several theories exist. Because of the very anatomic proximity between the auditory and vestibular systems, and their embryologic and physiologic alterations, they may be simultaneously involved in some bodily dysfunctions. This involvement is more frequent in peripheral alterations than in central ones.
The lateral wall and the fluid space are breached during cochleostomy. Insertion of electrode array may cause changes in the normal fluid homeostasis of the inner ear, damage to the basilar membrane, osseous spiral lamina and vestibular receptors; utricle, saccule and semicircular canals, surgery-induced inflammation resulting in fibrosis or loss of hair cells, foreign body reaction (labyrinthitis), produce perilymph leakage and alter the pressure in the inner ear. In addition, the electric stimulation of the cochlear implant may cause pathologic changes in the inner ear as a subsequent dysfunction of structures, resulting in vestibular alterations.
In previous research, the following vestibular assessments were utilized to determine vestibular injuries after CI: Caloric response, videonystagmography (VNG), vestibular-evoked myogenic potentials (VEMPs), video head impulse test (VHIT), rotatory chair and scleral search coil.
Knowledge of vestibular system function before and after CI surgery is important for the satisfactory management of each case. It also helps in the selection of which ear to implant to avoid bilateral vestibular areflexia and can assist in the management of any postoperative vestibular symptoms. So, there are two questions that should be raised when we consider the vestibular function of a patient who will submitted to CI: Is vestibular function present or not? and is the function symmetric?
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Vestibular Function in Cochlear Implanted Hearing Impaired Children|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2021|
- Head thrust test [ Time Frame: baseline ]Clinical test which assesses vestibuloocular (VOR) function in which examiner briskly rotate patient's head to both sides while patient fixate his eyes on a target and watch for corrective saccades on eye movements.
- Bruininks-Oseretsky test of motor proficiency (BOT-2) [ Time Frame: baseline ]Clinical balance test which assesses vestibulospinal (VSR) function, patient stand on a firm surface and on a soft cushion with eyes closed and eye open, a scoring system is obtained for all these balance situations.
- Caloric test [ Time Frame: baseline ]Objective test of VOR, includes irrigation of warm and\or cool water into patient's external auditory canal and measure the resulting nystagmus by a computerized system.
- Vestibular evoked myogenic potentials (VEMPs) [ Time Frame: baseline ]Objective test of vestibulocollic (VCR) function which assesses otolithic organs, VEMPs amplitudes and latencies are measured by a computerized system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599804
|Contact: Marwa Hu Hamza, Masterfirstname.lastname@example.org|
|Contact: Enass S Mohamed, MDemail@example.com|
|Study Director:||Enass S Mohamed, MD||Assiut universty|