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

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

Study Overview

• Status: Recruiting
• Conditions: Developmental Stuttering; Evoked Potentials Auditory
• Intervention / Treatment: Behavioral: Fluency shaping exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21500
    • Recruiting
    • Faculty of Medicine, Alexandria universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Children who stutter; 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	Behavioral: Fluency shaping exercises; Training for prolonged speech, easy onset, light contact and abdominal breathing moving from the level of single words till using short sentences describing pictures
NO_INTERVENTION: children who do not stutter; Measuring cortical auditory evoked potentials as a comparison group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alaa Mamdouh

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2021
• Primary Completion (ACTUAL): December 20, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (ACTUAL): July 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 5, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stuttering
• Other Study ID Numbers: 0201568; 00018699 (Other Identifier: Ethics committee Alexandria University); 00012098 (Other Identifier: Alexandria University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is not yet known if there would be a plane to make IPD available
• IPD Sharing Time Frame: anticipated 4 to 6 months for the data to be available
• IPD Sharing Access Criteria: Through the Email Address A_abdelhamed14@alexmed.edu.eg
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No