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Stuttering, AdultNCT06809387

Investigating the SMA's Role in Speech and Reading Fluency in PWS With rTMS

A study testing Brain stimulation in people with Stuttering, Adult, run by Medipol University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to study how a part of the brain called the supplementary motor area (SMA) is connected to speech and reading fluency in adults who stutter. Researchers will use a method called repetitive transcranial magnetic stimulation (rTMS) to learn more about this relationship. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Stuttering, Adult
What is being tested?
Brain stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2025to 15 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be over 18 years of age
  • Presence of developmental stuttering
  • Being right hand dominant

Who cannot join

  • Being under 18 years of age
  • The presence of a diagnosed brain lesion
  • Presence of intracranial metal implantation
  • Presence of a speech and language problem other than stuttering
  • The presence of a diagnosed neurological disorder
  • The presence of a diagnosed psychiatric disorder
  • Use of drugs and substances that may affect the central nervous system
  • History of epilepsy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site

  • İstanbul Medipol Üniversitesi Dil, Konuşma ve Yutma Terapisi ve Yenilikçi Teknolojiler Merkezi (MEDKOM)

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Investigating the Supplementary Motor Area Role in Speech and Reading Fluency in PWS With rTMS

The goal of this clinical trial is to study how a part of the brain called the supplementary motor area (SMA) is connected to speech and reading fluency in adults who stutter. Researchers will use a method called repetitive transcranial magnetic stimulation (rTMS) to learn more about this relationship. The main question it aims to answer is:

-Will participants' speech and reading fluency improve when we stimulate the SMA with rTMS?

Participants will take part in both placebo rTMS and real rTMS sessions.

Participants will:

  • Come to the research center for 2 days, with at least a one-week break between visits
  • Read 4 passages and speak on 4 topics
  • Be video recorded while doing these tasks
Being tested
Brain stimulation
Keywords
rTMS, stuttering, SMA
Medical subject headings
Stuttering

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain stimulationOther

    Participants will be included in the real and sham rTMS. Participants will perform speech and reading tasks before and after stimulation.

Study groups in NCT06809387
Study groupRoleWhat they receive
Real rTMSExperimentalParticipants will be included in the real rTMS. Participants will perform speech and reading tasks before and after stimulation.
Receives: Other: Brain stimulation
Sham rTMSPlacebo comparatorParticipants will be included in the sham rTMS. Participants will perform speech and reading tasks before and after stimulation.
Receives: Other: Brain stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severity of stuttering in speech and reading Day 1 (pre-treatment)

    Stuttering severity will be calculated on video recordings taken during speaking and reading tasks. Stuttering Severity Instrument - 4th Edition (SSI-4) scale will be used for this.

    Measured: Immediately before the treatment (Day 1)

  2. Severity of stuttering in speech and reading Day 1 (post-treatment)

    Stuttering severity will be calculated on video recordings taken during speaking and reading tasks. Stuttering Severity Instrument - 4th Edition (SSI-4) scale will be used for this.

    Measured: Immediately after the treatment (Day 1)

  3. Severity of stuttering in speech and reading Day 2 (pre-treatment)

    Stuttering severity will be calculated on video recordings taken during speaking and reading tasks. Stuttering Severity Instrument - 4th Edition (SSI-4) scale will be used for this.

    Measured: Immediately before the treatment (Day 2)

  4. Severity of stuttering in speech and reading Day 2 (post-treatment)

    Stuttering severity will be calculated on video recordings taken during speaking and reading tasks. Stuttering Severity Instrument - 4th Edition (SSI-4) scale will be used for this.

    Measured: Immediately after the treatment (Day 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start1 Jan 2025
  3. Primary completion15 Jun 2025 (estimated)
  4. Study completion15 Jun 2025 (estimated)

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06809387
Sponsor's protocol ID
E-10840098-202.3.02-645
Status last verified
Nov 2024
First submitted
26 Nov 2024
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.

    PubMed 9474057

  • Tezel-Bayraktaroglu O, Bayraktaroglu Z, Demirtas-Tatlidede A, Demiralp T, Oge AE. Neuronavigated rTMS inhibition of right pars triangularis anterior in stuttering: Differential effects on reading and speaking. Brain Lang. 2020 Nov;210:104862. doi: 10.1016/j.bandl.2020.104862. Epub 2020 Sep 23.

    PubMed 32979643

  • Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

    PubMed 19833552

  • Neef NE, Anwander A, Friederici AD. The Neurobiological Grounding of Persistent Stuttering: from Structure to Function. Curr Neurol Neurosci Rep. 2015 Sep;15(9):63. doi: 10.1007/s11910-015-0579-4.

    PubMed 26228377

  • Etchell AC, Civier O, Ballard KJ, Sowman PF. A systematic literature review of neuroimaging research on developmental stuttering between 1995 and 2016. J Fluency Disord. 2018 Mar;55:6-45. doi: 10.1016/j.jfludis.2017.03.007. Epub 2017 Mar 12.

    PubMed 28778745

  • Busan P, Del Ben G, Russo LR, Bernardini S, Natarelli G, Arcara G, Manganotti P, Battaglini PP. Stuttering as a matter of delay in neural activation: A combined TMS/EEG study. Clin Neurophysiol. 2019 Jan;130(1):61-76. doi: 10.1016/j.clinph.2018.10.005. Epub 2018 Nov 10.

    PubMed 30476712

  • Busan P. Developmental stuttering and the role of the supplementary motor cortex. J Fluency Disord. 2020 Jun;64:105763. doi: 10.1016/j.jfludis.2020.105763. Epub 2020 Apr 20.

    PubMed 32361030

  • Brown S, Ingham RJ, Ingham JC, Laird AR, Fox PT. Stuttered and fluent speech production: an ALE meta-analysis of functional neuroimaging studies. Hum Brain Mapp. 2005 May;25(1):105-17. doi: 10.1002/hbm.20140.

    PubMed 15846815

  • Alm PA. Stuttering and the basal ganglia circuits: a critical review of possible relations. J Commun Disord. 2004 Jul-Aug;37(4):325-69. doi: 10.1016/j.jcomdis.2004.03.001.

    PubMed 15159193

Questions about this trial

What is this clinical trial studying?

A study testing Brain stimulation in people with Stuttering, Adult, run by Medipol University at 1 site in Turkey (Türkiye).

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 8 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: enrolling by invitation, as of the sponsor's last update on 5 Feb 2025. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of stuttering in speech and reading Day 1 (pre-treatment) (time frame: Immediately before the treatment (Day 1)). 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 NCT06809387, which also lists 9 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 5 Feb 2025.

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