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Enrolling by invitationNCT06809387Updated Feb 5, 2025

Investigating the SMA's Role in Speech and Reading Fluency in PWS with RTMS

An interventional study of Brain stimulation in Stuttering, Adult, sponsored by Medipol University. Enrolling by invitation at 1 site in Turkey. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Medipol University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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. 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
02

Conditions studied

  • Stuttering, Adult

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Keywords

  • rTMS
  • stuttering
  • SMA
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 15 is below the median of 44 across 57 interventional studies indexed under Stuttering.

Browse Stuttering studies →

Lead sponsor

Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
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

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Real rTMS

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

    Other: Brain stimulation

  • Placebo comparator
    Sham rTMS

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

    Other: Brain stimulation

Interventions

  • OtherBrain stimulation

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Immediately after the treatment (Day 2)

07

Study locations

1 site
  • İstanbul Medipol Üniversitesi Dil, Konuşma ve Yutma Terapisi ve Yenilikçi Teknolojiler Merkezi (MEDKOM)
    İstanbul, Turkey
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

Time frame: January 2025-January 2026

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06809387
Lead sponsor
Medipol University
Responsible party
Gülkader Temiz (Principal Investigator, Medipol University) — Principal investigator
First posted
Feb 5, 2025
Start date
Jan 1, 2025
Primary completion
Jun 15, 2025 (estimated)
Completion
Jun 15, 2025 (estimated)
Last update
Feb 5, 2025

Oversight

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

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