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Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials

Primary Purpose

Developmental Stuttering, Evoked Potentials Auditory

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fluency shaping exercises
Sponsored by
Alaa Mamdouh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Developmental Stuttering

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Medicine, Alexandria universtiyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Children who stutter

children who do not stutter

Arm Description

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

Measuring cortical auditory evoked potentials as a comparison group

Outcomes

Primary Outcome Measures

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
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
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)
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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2022
Last Updated
February 5, 2023
Sponsor
Alaa Mamdouh
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1. Study Identification

Unique Protocol Identification Number
NCT05473572
Brief Title
Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials
Official Title
The Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials in School Age Children Who Stutter
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alaa Mamdouh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Stuttering, Evoked Potentials Auditory

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups group of children who stutter group of children who do not stutter
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children who stutter
Arm Type
Experimental
Arm Description
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
Arm Title
children who do not stutter
Arm Type
No Intervention
Arm Description
Measuring cortical auditory evoked potentials as a comparison group
Intervention Type
Behavioral
Intervention Name(s)
Fluency shaping exercises
Intervention Description
Training for prolonged speech, easy onset, light contact and abdominal breathing moving from the level of single words till using short sentences describing pictures
Primary Outcome Measure Information:
Title
Difference in latency of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter
Description
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
Title
Change in latency of cortical auditory evoked potentials in children with stuttering due to stuttering intervention program
Description
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
Title
Difference in amplitude of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter
Description
Measuring amplitude in microvolt of P1, N1 using the commercial system (Interacoustic Eclipse TM)
Time Frame
baseline: before intervention
Title
Change in amplitude of cortical auditory evoked potentials in children with stuttering due to stuttering intervention program
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa M Radwan, MS
Phone
0201159333807
Email
A_abdelhamed14@alexmed.edu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Engy S Elhakeem, PhD
Phone
201010566670
Email
engy.elhakeem@alex.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania M Abdou Mustafa, PhD
Organizational Affiliation
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed A Talaat, PhD
Organizational Affiliation
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Engy S Elhakeem, PhD
Organizational Affiliation
Otorhinolaryngology department,Faculty of Medicine, Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alaa M Radwan, MS
Organizational Affiliation
Otorhinolaryngology department, Faculty of Medicine, Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Alexandria universtiy
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa M Radwan, MS
Phone
0201159333807.
Email
A_abdelhamed14@alexmed.edu.com
First Name & Middle Initial & Last Name & Degree
Engy S Elhakeem, PhD
Phone
+201010566670
Email
engy.elhakeem@alexmed.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
28483259
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19796989
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.
Results Reference
background
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.
Results Reference
result
PubMed Identifier
14502069
Citation
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.
Results Reference
result

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Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials

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