Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials

NCT ID: NCT05473572

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Developmental Stuttering Evoked Potentials Auditory

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

two groups group of children who stutter group of children who do not stutter
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Fluency shaping exercises

Intervention Type 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 do not stutter

Measuring cortical auditory evoked potentials as a comparison group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alaa Mamdouh

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mamdouh

Assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rania M Abdou Mustafa, PhD

Role: STUDY_CHAIR

Otorhinolaryngology department,Faculty of Medicine, Alexandria University

Mohamed A Talaat, PhD

Role: STUDY_CHAIR

Otorhinolaryngology department,Faculty of Medicine, Alexandria University

Engy S Elhakeem, PhD

Role: STUDY_DIRECTOR

Otorhinolaryngology department,Faculty of Medicine, Alexandria University

Alaa M Radwan, MS

Role: PRINCIPAL_INVESTIGATOR

Otorhinolaryngology department, Faculty of Medicine, Alexandria University

Locations

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Faculty of Medicine, Alexandria universtiy

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Alaa M Radwan, MS

Role: CONTACT

0201159333807

Engy S Elhakeem, PhD

Role: CONTACT

201010566670

Facility Contacts

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Alaa M Radwan, MS

Role: primary

0201159333807.

Engy S Elhakeem, PhD

Role: backup

+201010566670

References

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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.

Reference Type BACKGROUND
PMID: 28483259 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 19796989 (View on PubMed)

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.

Reference Type 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.

Reference Type RESULT
PMID: 14502069 (View on PubMed)

Other Identifiers

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00012098

Identifier Type: OTHER

Identifier Source: secondary_id

00018699

Identifier Type: OTHER

Identifier Source: secondary_id

0201568

Identifier Type: -

Identifier Source: org_study_id

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