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Enrolling by invitation NCT06809387

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

No phase Interventional Stuttering, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brain stimulation.
Who it may be relevant to
Registry conditions: Stuttering, Adult. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Severity of stuttering in speech and reading Day 1 (pre-treatment) [Time frame: Immediately before the treatment (Day 1)]
  • Severity of stuttering in speech and reading Day 1 (post-treatment) [Time frame: Immediately after the treatment (Day 1)]
  • Severity of stuttering in speech and reading Day 2 (pre-treatment) [Time frame: Immediately before the treatment (Day 2)]
  • Severity of stuttering in speech and reading Day 2 (post-treatment) [Time frame: Immediately after the treatment (Day 2)]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • İstanbul Medipol Üniversitesi Dil, Konuşma ve Yutma Terapisi ve Yenilikçi Teknolojiler Mer — Istanbul

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 15846815

Identifiers

NCT: NCT06809387 · E-10840098-202.3.02-645

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗