Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants

Hearing Loss, Sensorineural Clinical Trial

Official title:

Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03352154
• Other study ID #: 38224814.2.0000.5440
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2016
• Est. completion date: June 4, 2020

Study information

• Verified date: March 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI.

Description:

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI. Twenty patients with bilateral severe and/or profound post-lingual deafness, all submitted to CI surgery, will be evaluated. Patients will be evaluated through P300 testing on the day before CI surgery, on the day of device activation and 6 months after device use. It is hoped that this study can contribute to the understanding of the mechanisms of brain plasticity involved in the recovery of hearing function after CI surgery. There are few studies on the behavior of P300 in CI users and there are no studies showing how central stimulation occurs after device implantation, during the phases of pre CI, CI activation and 6 months after CI.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with post-lingual hearing loss undergoing cochlear implant surgery

Exclusion Criteria:

• Prelingual hearing loss

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Diagnostic Test:
• P300 - Auditory long latency potential
Perform the P300 exams.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

References & Publications (13)

Beynon AJ, Snik AF, Stegeman DF, van den Broek P. Discrimination of speech sound contrasts determined with behavioral tests and event-related potentials in cochlear implant recipients. J Am Acad Audiol. 2005 Jan;16(1):42-53. — View Citation

Calháu CM, Lima Júnior LR, Reis AM, Capistrano AK, Lima Ddo V, Calháu AC, Rodrigues Júnior Fde A. [Etiology profile of the patients implanted in the cochlear implant program]. Braz J Otorhinolaryngol. 2011 Jan-Feb;77(1):13-8. Portuguese. — View Citation

Diniz Júnior J, Mangabeira-Albernaz PL, Munhoz MS, Fukuda Y. Cognitive potentials in children with learning disabilities. Acta Otolaryngol. 1997 Mar;117(2):211-3. — View Citation

Duarte Josilene Luciene, Alvarenga Kátia de Freitas, Costa Orozimbo Alves. Potencial cognitivo P300 realizado em campo livre: aplicabilidade do teste. Rev. Bras. Otorrinolaringol. [Internet]. 2004 Dec [cited 2015 May 02] ; 70( 6 ): 780-785.

Groenen PA, Makhdoum M, van den Brink JL, Stollman MH, Snik AF, van den Broek P. The relation between electric auditory brain stem and cognitive responses and speech perception in cochlear implant users. Acta Otolaryngol. 1996 Nov;116(6):785-90. — View Citation

Jasper H. A. (1958). The ten-twenty electrode system of the international federation. Electroencephalogr. Clin. Neurophysiol. 10, 371-375

Jordan K, Schmidt A, Plotz K, von Specht H, Begall K, Roth N, Scheich H. Auditory event-related potentials in post- and prelingually deaf cochlear implant recipients. Am J Otol. 1997 Nov;18(6 Suppl):S116-7. — View Citation

Kelly AS, Purdy SC, Thorne PR. Electrophysiological and speech perception measures of auditory processing in experienced adult cochlear implant users. Clin Neurophysiol. 2005 Jun;116(6):1235-46. Epub 2005 Apr 26. — View Citation

Kileny PR. Use of electrophysiologic measures in the management of children with cochlear implants: brainstem, middle latency, and cognitive (P300) responses. Am J Otol. 1991;12 Suppl:37-42; discussion 43-7. — View Citation

McPherson, D.L. Late potentials of the auditory system. San Diego: Singular Publishing Group; 1996.

Micco AG, Kraus N, Koch DB, McGee TJ, Carrell TD, Sharma A, Nicol T, Wiet RJ. Speech-evoked cognitive P300 potentials in cochlear implant recipients. Am J Otol. 1995 Jul;16(4):514-20. — View Citation

Mühler R, Ziese M, Kevanishvili Z, Schmidt M, von Specht H. Visualization of stimulation patterns in cochlear implants: application to event-related potentials (P300) in cochlear implant users. Ear Hear. 2004 Apr;25(2):186-90. — View Citation

Okusa M, Shiraishi T, Kubo T, Nageishi Y. Effects of discrimination difficulty on cognitive event-related brain potentials in patients with cochlear implants. Otolaryngol Head Neck Surg. 1999 Nov;121(5):610-5. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the P300 Responses after CI	Improving the cognitive process on CI receivers	06 months after CI