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

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Non-randomized
Ages: 18 Years and older
Sex: Male

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

Conditions studied

Stuttering, Adult

Browse trials for

Stuttering 72

Keywords

rTMS
stuttering
SMA

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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.

What researchers measure

Primary outcomes

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)
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)
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)
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)

Study locations

1 site

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

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, Sap

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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