Clinical trial NCT06809387: Investigating the SMA's Role in Speech and Reading Fluency in PWS With rTMS
Official title: Investigating the Supplementary Motor Area Role in Speech and Reading Fluency in PWS With rTMS
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stuttering, Adult
Keywords: rTMS
stuttering
SMA
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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


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

Primary outcomes:
measure: Severity of stuttering in speech and reading Day 1 (pre-treatment)
timeFrame: Immediately before the treatment (Day 1)
measure: Severity of stuttering in speech and reading Day 1 (post-treatment)
timeFrame: Immediately after the treatment (Day 1)
measure: Severity of stuttering in speech and reading Day 2 (pre-treatment)
timeFrame: Immediately before the treatment (Day 2)
measure: Severity of stuttering in speech and reading Day 2 (post-treatment)
timeFrame: Immediately after the treatment (Day 2)
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Medipol Üniversitesi Dil, Konuşma ve Yutma Terapisi ve Yenilikçi Teknolojiler Merkezi (MEDKOM)
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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