An explorative study on cortical activation in normal hearing and in deaf adults, before and after cochlear implantation, measured with fMRI and NIRS.

• Conditions: sensorineural hearing loss; severe hearing loss and deafness; 10013995; 10019243

• Registration Number: NL-OMON32742
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Adults (18 years of age or older)
2. Right handed
3. Normal hearing group: having a pure-tone air conduction thresholds <= 15 dB HL
4. Unilaterally implanted pre-lingual deaf group: profound sensorineural hearing loss during the first 1.5 years of life
a. Implanted group with good results: consonant-vowel-consonant (CVC) score > 50% (open-set monosyllable lists according to the *Nederlandse Vereniging van Audiologie* (NVA)).
b. Implanted group with poor results: consonant-vowel-consonant (CVC) score < 50% (open-set, monosyllable lists according to NVA).
5. Prelingual deaf CI candidates: deaf or profound sensorineural hearing loss during the first 3 years of life, 90 dB < Pure tone average <120 dB

Exclusion Criteria

1.Pregnancy/breastfeeding
2.Subjects with intracorporeal metal components or electronic devices
3.Claustrophobic

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A fMRI scan measured the cerebral blood flow (and hence the cortical activity)<br /><br>by differences in the regional Blood Oxygen Level Dependent (BOLD) response<br /><br>between activated and baseline (or control) condition.<br /><br><br /><br>To study the brain activity with NIRS, local changes in cortical oxy- and<br /><br>deoxyhemoglobin concentration are evaluated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>