Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials

NCT05473572 | Unknown

• 3 other identifiers: 02015680001209800018699
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Developmental Stuttering; Evoked Potentials Auditory

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Children who stutter

EXPERIMENTAL

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

children who do not stutter

NO INTERVENTION

Measuring cortical auditory evoked potentials as a comparison group

Interventions

Fluency shaping exercises BEHAVIORAL

Training for prolonged speech, easy onset, light contact and abdominal breathing moving from the level of single words till using short sentences describing pictures

Children who stutter

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alaa Mamdouh: lead

Study Sites (1)

Faculty of Medicine, Alexandria universtiy

Alexandria, 21500, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 28483259 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19796989 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 14502069 RESULT

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rania M Abdou Mustafa, PhD

  Otorhinolaryngology department,Faculty of Medicine, Alexandria University

  STUDY CHAIR

• Mohamed A Talaat, PhD

  Otorhinolaryngology department,Faculty of Medicine, Alexandria University

  STUDY CHAIR

• Engy S Elhakeem, PhD

  Otorhinolaryngology department,Faculty of Medicine, Alexandria University

  STUDY DIRECTOR

• Alaa M Radwan, MS

  Otorhinolaryngology department, Faculty of Medicine, Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa M Radwan, MS

CONTACT

0201159333807; A_abdelhamed14@alexmed.edu.com

Engy S Elhakeem, PhD

CONTACT

201010566670; engy.elhakeem@alex.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: two groups group of children who stutter group of children who do not stutter

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 26, 2022
• Study Start: August 17, 2021
• Primary Completion: December 20, 2022
• Study Completion: March 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: anticipated 4 to 6 months for the data to be available
• Access Criteria: Through the Email Address A\ abdelhamed14@alexmed.edu.eg

Locations

EG (1)