Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-21
SponsorNYU Langone Health
About this trial
This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results. Data obtained in the course of this study will be compared with the existing published outcome data from children with normal hearing and with cochlear implants (CIs). These comparisons may provide additional useful information about the progress of ABI subjects' performance over time. Also, this may allow the results of the current study to be utilized to design future pivotal studies of the device in the pediatric population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cochlear nerve deficiency
Cochlear aplasia or severe hypoplasia
Severe inner ear malformation
Post-meningitis ossification
Disqualifiers
Pre- or post-linguistic child currently making significant progress with CI Even for the very young children (18 months of age with 6 months of use), nearly all children with a good auditory signal from their CI will show evidence of improvement in these metrics over time.
normal cochlea and cochlear nerves or NF2
brainstem or cortical anomaly that makes implantation unfeasible
Clear surgical reason for poor CI performance that can be remediated with revision CI or contralateral surgery rather than ABI.
Trial design
Design model
Single group
Treatments tested in this trial
Nucleus ABI541 Auditory Brainstem Implant
DeviceSurgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Pre-lingual DeafnessExperimental treatment 1 intervention
Group B: Post-Lingual DeafnessExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ABI Device Complications
Study participants will be monitored on a case-by-case basis for ongoing or unanticipated medical complications. Adverse events will be tracked on a case-by-case basis and recorded at the time of occurrence and followed up at resolution. Any adverse events will be reported to the NYUSOM IRB. Should there be concern for the safety of the subjects because of their participation in the study by the investigators or the IRB, the study would be halted at least temporarily and a detailed discussion with the investigators and the IRB would be undertaken.
Time frame
5 Years from date of surgerySecondary outcomes
1
Audiologic Performance with ABI (Hearing, Speech and Language Assessments)
The following audiometry and speech perception tests will be administered as age-appropriate: * Detection audiogram, aided and unaided individual ears * IT-MAIS or MAIS * LING 6 sound test * ESP Low Verbal or Standard- MLV @ 50dB HL * PB-k words and phonemes- MLV @ 50dB HL * MLNT- recorded @ 60dB SPL * LNT- recorded @ 60dB SPL * HINT-C- 2 lists of 10 @ 60dB SPL * CNC- 50 words @ 60dB SPL Each child will receive speech/language intervention using the Comprehensive Assessment of Spoken Language (CASL, Elizabeth Carrow-Woolfolk, 1999) The following tests will be administered when appropriate: * The Oral and Written Language Scales (OWLS) * Goldman-Fristoe Test of Articulation * The Peabody Picture Vocabulary Test (PPVT) * The Rossetti Infant-Toddler Language Scale * Pre-School Language Scale, (PLS-5) * The Expressive Vocabulary Test, 2nd Ed * The Peabody Picture Vocabulary Test, 4th Ed
Time frame
36 months from date of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov