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Signal Processing Intervention

Image-Guided Programming for Cochlear Implants

N/A
Recruiting
Led By Rene Gifford, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prelingual onset of deafness
At least one CI and bilateral moderate to profound sensorineural hearing loss
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post intervention
Awards & highlights

Study Summary

This trial will test whether children with cochlear implants have improved speech and language ability relative to previous generations of children with hearing loss.

Who is the study for?
This trial is for children aged 4-12 with cochlear implants, implanted before age 4 due to prelingual deafness. They must have moderate to profound sensorineural hearing loss in both ears (or the non-CI ear), no severe cognitive impairments or disorders like autism, and typical nonverbal cognitive abilities. Severe temporal bone abnormalities or postlingual onset of hearing loss are disqualifiers.Check my eligibility
What is being tested?
The study tests a new method called Image-guided Cochlear Implant Programming (IGCIP) that uses CT scans to map the relationship between implant electrodes and neural interface for better customization. It aims to see if this personalized mapping improves speech and language outcomes in kids with cochlear implants.See study design
What are the potential side effects?
Since this intervention involves programming adjustments rather than medication, traditional side effects aren't expected. However, there may be risks associated with additional CT scans required for mapping such as exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been deaf since birth or before I learned to speak.
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I have severe hearing loss in both ears.
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My child is between 4 and 12 years old.
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I received a cochlear implant before I was 4 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Spectral resolution (spectral modulation detection or SMD)
Secondary outcome measures
Temporal resolution (sinusoidal amplitude modulation (SAM) detection

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate IGCIPExperimental Treatment1 Intervention
Immediate signal processing intervention of a biomedical device
Group II: Deferred IGCIPActive Control1 Intervention
Delayed signal processing intervention of a biomedical device

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,121 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
330 Previous Clinical Trials
178,399 Total Patients Enrolled
Rene Gifford, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Cochlear Implants Research Study Groups: Deferred IGCIP, Immediate IGCIP

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment presently enlisting participants?

"The information displayed on clinicaltrials.gov states that this trial is actively recruiting participants as of August 5, 2022. It was first available for enrollment in June 30, 2019."

Answered by AI

How many people are engaged in this trial's research?

"Yes, according to information on clinicaltrials.gov, this study is currently attempting to enroll participants. It was first posted on June 30th 2019 and its most recent update occurred on August 5th 2022. The researchers are hoping to secure 72 patients across a single site."

Answered by AI

Who meets the criteria to take part in this research study?

"This medical trial is searching for 72 children aged between 4 and 12 years old, who have been implanted with a cochlear device."

Answered by AI

Is the participation of individuals over 50 years old permissible in this clinical experiment?

"This clinical experiment is seeking subjects aged between 4 and 12 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pediatric Image-Guided Cochlear Implant Programming
René Gifford 2019. "Pediatric Image-Guided Cochlear Implant Programming". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03886168.
~11 spots leftby Mar 2025
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