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Auditory Brainstem Implant for Pediatric Deafness

Phase 1

Waitlist Available

Led By Eric Wilkinson, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post-device activation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years post-device activation

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary endpoint

Secondary outcome measures

Secondary endpoint: Preliminary efficacy

Unexpected Serious Adverse Events

Trial Design

1Treatment groups

Experimental Treatment

Group I: ExperimentalExperimental Treatment1 Intervention

Device Implantation

0 / 1Eligibility criteria met

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

495 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

Frequently Asked Questions

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

Is this trial open to those aged 18 and over?

"This medical experiment has set the age limit for participants between 2 and 6 years old. There are 65 clinical studies available to those below 18, while 153 have been made accessible to seniors over the age of 65."

Answered by AI

Does my profile comply with the criteria for taking part in this trial?

"This investigation requires 10 patients aged between 2 and 6 who experience hearing impairment. Moreover, those previously implanted with a cochlear implant must have registered no benefit from its application."

Answered by AI

Are there any available slots for participants in this research?

"Per the data posted on clinicaltrials.gov, this specific medical trial is not accepting new participants as of now. The experiment was first published in March 2014 and was last revised in February 2019. However, there are 195 other trials actively searching for patients at present."

Answered by AI