Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials

Developmental Stuttering Clinical Trial

Official title:

The Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials in School Age Children Who Stutter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473572
• Other study ID #: 0201568
• Secondary ID: 0001209800018699
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: March 2023

Study information

• Verified date: February 2023
• Source: Alexandria University
• Contact: Alaa M Radwan, MS
• Phone: 0201159333807
• Email: A_abdelhamed14[@]alexmed.edu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: March 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Stuttering
• Stuttering

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria universtiy	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alaa Mamdouh

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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.

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. — View 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. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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