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Status unknownNCT05473572Updated Feb 8, 2023

Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials

An interventional study of Fluency shaping exercises in Developmental Stuttering and Evoked Potentials Auditory, sponsored by Alaa Mamdouh. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Alaa Mamdouh · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Aug 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Developmental Stuttering
  • Evoked Potentials Auditory

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03

In context

Stuttering

74 studies on the registry are indexed under Stuttering; 23 are open to participants now.

This study's planned enrollment of 34 is below the median of 44 across 57 interventional studies indexed under Stuttering.

Browse Stuttering studies →

Lead sponsor

Alaa Mamdouh is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Known history of epileptic fits.
  • Intellectual disability and other neurological deficits.
  • Cluttering
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • 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

  • No intervention
    children who do not stutter

    Measuring cortical auditory evoked potentials as a comparison group

Interventions

  • BehavioralFluency 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline: before intervention

  2. 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

    Time frame: immediately after intervention

  3. 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)

    Time frame: baseline: before intervention

  4. 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

    Time frame: immediately after intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 28483259 ↗
  • 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. PubMed 19796989 ↗
  • 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. PubMed 14502069 ↗

Individual participant data

Plan to share: Yes — It is not yet known if there would be a plane to make IPD available

Supporting information: Study protocol, Statistical analysis plan, Clinical study report, 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05473572
Lead sponsor
Alaa Mamdouh
Responsible party
Alaa Mamdouh (Assistant lecturer, Alexandria University) — Sponsor-investigator
First posted
Jul 26, 2022
Start date
Aug 17, 2021
Primary completion
Dec 20, 2022
Completion
Mar 2023 (estimated)
Last update
Feb 8, 2023

Study contacts

Alaa M Radwan, MS
Contact
A_abdelhamed14@alexmed.edu.com
0201159333807
Engy S Elhakeem, PhD
Contact
engy.elhakeem@alex.edu.eg
201010566670
Rania M Abdou Mustafa, PhD
study chair · Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Mohamed A Talaat, PhD
study chair · Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Engy S Elhakeem, PhD
study director · Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Alaa M Radwan, MS
principal investigator · Otorhinolaryngology department, Faculty of Medicine, Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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