Clinical trial NCT05473572: Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials
Official title: The Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials in School Age Children Who Stutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Stuttering
Evoked Potentials Auditory
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups group of children who stutter group of children who do not stutter
Primary purpose: OTHER

Brief summary: studying how the cortical auditory evoked potentials differ in children who stutter from who do not stutter and how these potentials change with therapy

Detailed description: Measuring amplitude and latency of P1, N1, P2 N2 between a group with developmental stuttering and a control group with no stuttering at baseline. Recording the potentials through passive listening to a 60dB stimulus and active speaking, describing pictures and rapid naming.

Assigning the group with stuttering to remediation exercises using fluency shaping program for 2 to 4 months then remeasuring amplitude and latency of the previously mentioned potentials.

Eligibility criteria: Inclusion criteria:

* Patients with developmental stuttering
* Normal hearing and vision.
* Adequate language for age.

Exclusion criteria:

* Known history of epileptic fits.
* Intellectual disability and other neurological deficits.
* Cluttering

Primary outcomes:
measure: Difference in latency of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter
timeFrame: baseline: before intervention
measure: Change in latency of cortical auditory evoked potentials in children with stuttering due to stuttering intervention program
timeFrame: immediately after intervention
measure: Difference in amplitude of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter
timeFrame: baseline: before intervention
measure: Change in amplitude of cortical auditory evoked potentials in children with stuttering due to stuttering intervention program
timeFrame: immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria universtiy
Study officials:
affiliation: Otorhinolaryngology department,Faculty of Medicine, Alexandria University
name: Rania M Abdou Mustafa, PhD
role: STUDY_CHAIR
affiliation: Otorhinolaryngology department,Faculty of Medicine, Alexandria University
name: Mohamed A Talaat, PhD
role: STUDY_CHAIR
affiliation: Otorhinolaryngology department,Faculty of Medicine, Alexandria University
name: Engy S Elhakeem, PhD
role: STUDY_DIRECTOR
affiliation: Otorhinolaryngology department, Faculty of Medicine, Alexandria University
name: Alaa M Radwan, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.