Developmental StutteringNCT05473572
Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials
A study testing Fluency shaping exercises in people with Developmental Stuttering and Evoked Potentials Auditory, run by Alaa Mamdouh at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Stuttering, Evoked Potentials Auditory
- What is being tested?
- Fluency shaping exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Aug 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with developmental stuttering
- Normal hearing and vision.
- Adequate language for age.
Who cannot join
- Known history of epileptic fits.
- Intellectual disability and other neurological deficits.
- Cluttering
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Alexandria universtiy
Alexandria, 21500
Alaa M Radwan, MS, 0201159333807., A_abdelhamed14@alexmed.edu.com
Engy S Elhakeem, PhD, +201010566670, engy.elhakeem@alexmed.edu.eg
About this study
Official title: The Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials in School Age Children Who Stutter
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.
- Being tested
- Fluency shaping exercises
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluency shaping exercisesBehavioural
Training for prolonged speech, easy onset, light contact and abdominal breathing moving from the level of single words till using short sentences describing pictures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Fluency shaping exercises |
| children who do not stutter | No intervention | Measuring cortical auditory evoked potentials as a comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start17 Aug 2021
- Primary completion20 Dec 2022
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Developmental StutteringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups group of children who stutter group of children who do not stutter
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaa Mamdouh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mamdouh, Alexandria University
- Investigators
- Rania M Abdou Mustafa, PhD, Study chair, Otorhinolaryngology department,Faculty of Medicine, Alexandria UniversityMohamed A Talaat, PhD, Study chair, Otorhinolaryngology department,Faculty of Medicine, Alexandria UniversityEngy S Elhakeem, PhD, Study director, Otorhinolaryngology department,Faculty of Medicine, Alexandria UniversityAlaa M Radwan, MS, Principal investigator, Otorhinolaryngology department, Faculty of Medicine, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473572
- Sponsor's protocol ID
- 0201568
- Other IDs
- 00012098, 00018699
- Status last verified
- Feb 2023
- First submitted
- 15 Jul 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is not yet known if there would be a plane to make IPD available
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 28483259Abdou 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 19796989Packman 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials in School Age Children Who Stutter
- ClinicalTrials.gov ID
- NCT05473572
- Acronym / sponsor ID
- 0201568
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Alaa MamdouhUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups group of children who stutter group of children who do not stutter
| Arm | Type | Receives |
|---|---|---|
| Children who stutter | Experimental | Behavioral: Fluency shaping exercisesMeasuring 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 |
| children who do not stutter | No intervention | –Measuring cortical auditory evoked potentials as a comparison group |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with developmental stuttering
- Normal hearing and vision.
- Adequate language for age.
Key exclusion criteria (3 listed)
- Known history of epileptic fits.
- Intellectual disability and other neurological deficits.
- Cluttering
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluency shaping exercisesTraining for prolonged speech, easy onset, light contact and abdominal breathing moving from the level of single words till using short sentences describing pictures | Behavioural | Children who stutter |
Primary outcome
Difference in latency of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter
Time frame: baseline: before intervention
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
Time frame: immediately after intervention
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
Time frame: baseline: before intervention
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
Time frame: immediately after intervention
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 28483259Ismail 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.
- BackgroundAbdou 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: PubMed 19796989Duncan 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 publicationPackman 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 publication: PubMed 14502069Cone-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.
- Individual participant dataSharing planned: Yes. It is not yet known if there would be a plane to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluency shaping exercises in people with Developmental Stuttering and Evoked Potentials Auditory, run by Alaa Mamdouh at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa M Radwan, MS (0201159333807, A_abdelhamed14@alexmed.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in latency of cortical auditory evoked potentials in children with stuttering compared to children who do do not stutter (time frame: baseline: before intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473572, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.