NCT05473572|Unknown
Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials
The Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials in School Age Children Who Stutter
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The Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials in School Age Children Who Stutter
Sponsor study identifier
Secondary identifiers
OTHER · IRB
OTHER · FWA
interventional
34
1 country
1
Study Start
August 17, 2021
Actual (reported)Primary Completion
December 20, 2022
Actual (reported)Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
studying how the cortical auditory evoked potentials differ in children who stutter from who do not stutter and how these potentials change with therapy
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2021
Actual (reported)July 15, 2022
Actual (reported)July 26, 2022
Actual (reported)December 20, 2022
Actual (reported)March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Difference in latency of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter
Measuring latency in millisecond of P1, N1 using the commercial system (Interacoustic Eclipse TM) device during passive listening to a 60dB auditory stimulus and active speaking conditions
baseline: before intervention
Change in latency of cortical auditory evoked potentials in children with stuttering due to stuttering intervention program
Measuring latency in millisecond of P1, N1 in the group who stutter after intervention using the commercial system (Interacoustic Eclipse TM) device during passive listening to a 60dB auditory stimulus and active speaking conditions
immediately after intervention
Difference in amplitude of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter
Measuring amplitude in microvolt of P1, N1 using the commercial system (Interacoustic Eclipse TM)
baseline: before intervention
Change in amplitude of cortical auditory evoked potentials in children with stuttering due to stuttering intervention program
Measuring amplitude in microvolt of P1, N1 in the group who stutter after intervention using the commercial system (Interacoustic Eclipse TM) device during passive listening to a 60dB auditory stimulus and active speaking conditions
immediately after intervention
Measuring stuttering severity and cortical auditory evoked potentials in a group of children who stutter then they will receive fluency shaping exercises for a period range from 2-4 months. Reassessment of cortical auditory evoked potentials and stuttering severity after the specified period
Measuring cortical auditory evoked potentials as a comparison group
Training for prolonged speech, easy onset, light contact and abdominal breathing moving from the level of single words till using short sentences describing pictures
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Faculty of Medicine, Alexandria universtiy
Alexandria, 21500, Egypt
Ismail N, Sallam Y, Behery R, Al Boghdady A. Cortical auditory evoked potentials in children who stutter. Int J Pediatr Otorhinolaryngol. 2017 Jun;97:93-101. doi: 10.1016/j.ijporl.2017.03.030. Epub 2017 Apr 3.
Abdou R. Assessment of Egyptian children who stutter using the standardized Arabic form of the Test of Childhood Stuttering. The Egyptian Journal of Otolaryngology. 2015;31(3):180-7.
Duncan CC, Barry RJ, Connolly JF, Fischer C, Michie PT, Naatanen R, Polich J, Reinvang I, Van Petten C. Event-related potentials in clinical research: guidelines for eliciting, recording, and quantifying mismatch negativity, P300, and N400. Clin Neurophysiol. 2009 Nov;120(11):1883-1908. doi: 10.1016/j.clinph.2009.07.045. Epub 2009 Sep 30.
Rania M Abdou Mustafa, PhD
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Mohamed A Talaat, PhD
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Engy S Elhakeem, PhD
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Alaa M Radwan, MS
Otorhinolaryngology department, Faculty of Medicine, Alexandria University
First Submitted
July 15, 2022
First Posted
July 26, 2022
Study Start
August 17, 2021
Actual (reported)Primary Completion
Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
Transcranial Alternating Current Stimulation (tACS) in Stuttering
Contact the study team to confirm eligibility.
Packman A, Attanasio J, editors. A model of the mechanisms underpinning early interventions for stuttering. Seminar presentation at the annual convention of the American Speech-Language and Hearing Association Philadelphia, USA; 2010.
Cone-Wesson B, Wunderlich J. Auditory evoked potentials from the cortex: audiology applications. Curr Opin Otolaryngol Head Neck Surg. 2003 Oct;11(5):372-7. doi: 10.1097/00020840-200310000-00011.
December 20, 2022
Study Completion
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 8, 2023
Record last verified: 2023-02
It is not yet known if there would be a plane to make IPD available
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Source: ClinicalTrials.gov.
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