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Auditory Brainstem Implant for Pediatric Deafness

Phase 1
Waitlist Available
Led By Laurie S. Eisenberg, PhD
Research Sponsored by Laurie Eisenberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
Be younger than 18 years old
Must not have
Medical contraindication to craniotomy/intracranial surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post-device activation
Awards & highlights

Summary

This trial will study the safety of auditory brainstem implants (ABI) in children aged 2-5 who cannot benefit from cochlear implants.

Who is the study for?
This trial is for children aged 2-5 with profound deafness who can't use cochlear implants due to inner ear issues or have not benefited from one. They should be able to undergo brain surgery, without severe cognitive or developmental delays.
What is being tested?
The study tests the safety of an Auditory Brainstem Implant (ABI) in young kids. It involves placing an electrode near the auditory nucleus in the brainstem and monitoring the child for safety over a year and efficacy for three years.
What are the potential side effects?
While specific side effects are not listed, potential risks may include those associated with craniotomy/intracranial surgery such as infection, bleeding, nerve damage, and reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am profoundly deaf due to inner ear or nerve issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot undergo brain surgery due to health risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post-device activation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post-device activation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary endpoint
Secondary study objectives
Secondary endpoint: Preliminary efficacy
Unexpected Serious Adverse Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Device Implantation

Find a Location

Who is running the clinical trial?

Keck School of Medicine of USCUNKNOWN
5 Previous Clinical Trials
700 Total Patients Enrolled
Laurie EisenbergLead Sponsor
Huntington Medical Research InstitutesOTHER
5 Previous Clinical Trials
492 Total Patients Enrolled

Media Library

Auditory Brainstem Implant (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02102256 — Phase 1
Bilateral Deafness Research Study Groups: Experimental
Bilateral Deafness Clinical Trial 2023: Auditory Brainstem Implant Highlights & Side Effects. Trial Name: NCT02102256 — Phase 1
Auditory Brainstem Implant (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02102256 — Phase 1
~1 spots leftby Sep 2025
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