Hearing Loss, Bilateral (Causes Other Than Tumors) Clinical Trial
Official title:
Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves
| NCT number | NCT02310399 |
| Other study ID # | S14-01010 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | May 1, 2027 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | May 1, 2027 |
| Est. primary completion date | May 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Months to 21 Years |
| Eligibility | Inclusion Criteria: Group 1: Prelinguistic hearing loss (birth-5 years; age at implantation of ABI 18 months-5 years) • Pre-linguistic hearing loss (birth-5 yrs.; age at ABI 18 months-5yrs) with both: - MRI +/- CT evidence of one of the following: - Cochlear nerve deficiency - Cochlear aplasia or severe hypoplasia - Severe inner ear malformation - Post-meningitis ossification - When a cochlea is present or patent, lack of significant benefit from CI despite consistent use (>6 mo.) - No or limited speech perception ability (limited to pattern perception on closed set testing materials using the CI) - Lack of progress in auditory skills development Group 2: Post-linguistic hearing loss (<21 yrs. of age) - Post-linguistic hearing loss (<21 yrs. of age) with: - Loss or lack of benefit from appropriate CI without the possibility for revision or contralateral implantation. Examples might include: - Post-meningitis ossification - Bilateral temporal bone fractures with cochlear nerve avulsion - Failed revision CI without benefit - Previously developed open set speech perception and auditory-oral language skills - No medical contraindications - Willing to receive the appropriate meningitis vaccinations - No or limited cognitive/developmental delays. - Strong family support - Reasonable expectations from parents/guardians including a thorough understanding: - of potential benefits and limitations of ABI - of parental role in rehabilitation - that the child may not develop spoken language as a primary communication mode or even sufficient spoken language to make significant academic progress in an aural/oral environment - Involvement in a rehabilitation program that emphasizes development of auditory skills with or without the use of supplementary visual communication. - Able to comply with study requirements including travel to investigation sites. - Informed consent for the procedure from the child's parents/legal guardian. Exclusion Criteria: For both Groups 1 and 2: - 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. - MRI evidence of one of the following: - 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. - Intractable seizures or progressive, deteriorating neurological disorder - Patients with evidence of Chiari malformation, hydrocephalus, spina bifid a - Patients with any foreseeable need for a future MRI scan - Unable to participate in behavioral testing and mapping with their CI. If this appears to be an age effect, ABI will be delayed until we can be assured that the child will be able to participate, as reliable objective measures of mapping are currently not available for mapping these devices. - Unable to tolerate general anesthesia (cardiac, pulmonary, bleeding diathesis, etc.). - Need for brainstem irradiation - Unrealistic expectations on the part of the subject/family regarding the possible benefits, risks and limitations inherent to the procedure and ABI device. - Unwilling to sign the informed consent. - Unwilling to make necessary follow-up appointments. |
| Country | Name | City | State |
|---|---|---|---|
| United States | NYU Cochlear Implant Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| NYU Langone Health |
United States,
Colletti L, Shannon RV, Colletti V. The development of auditory perception in children after auditory brainstem implantation. Audiol Neurootol. 2014;19(6):386-94. doi: 10.1159/000363684. Epub 2014 Nov 4. — View Citation
Colletti L, Wilkinson EP, Colletti V. Auditory brainstem implantation after unsuccessful cochlear implantation of children with clinical diagnosis of cochlear nerve deficiency. Ann Otol Rhinol Laryngol. 2013 Oct;122(10):605-12. — View Citation
Colletti L, Zoccante L. Nonverbal cognitive abilities and auditory performance in children fitted with auditory brainstem implants: preliminary report. Laryngoscope. 2008 Aug;118(8):1443-8. doi: 10.1097/MLG.0b013e318173a011. — View Citation
Colletti V, Shannon R, Carner M, Veronese S, Colletti L. Outcomes in nontumor adults fitted with the auditory brainstem implant: 10 years' experience. Otol Neurotol. 2009 Aug;30(5):614-8. doi: 10.1097/MAO.0b013e3181a864f2. — View Citation
Sennaroglu L, Ziyal I, Atas A, Sennaroglu G, Yucel E, Sevinc S, Ekin MC, Sarac S, Atay G, Ozgen B, Ozcan OE, Belgin E, Colletti V, Turan E. Preliminary results of auditory brainstem implantation in prelingually deaf children with inner ear malformations including severe stenosis of the cochlear aperture and aplasia of the cochlear nerve. Otol Neurotol. 2009 Sep;30(6):708-15. doi: 10.1097/MAO.0b013e3181b07d41. — View Citation
Sennaroglu L, Ziyal I. Auditory brainstem implantation. Auris Nasus Larynx. 2012 Oct;39(5):439-50. doi: 10.1016/j.anl.2011.10.013. Epub 2011 Dec 22. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 5 Years from date of surgery | |
| Secondary | 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 |
36 months from date of surgery |