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

NCT ID: NCT06809387

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-06-15

Brief Summary

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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

Detailed Description

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Conditions

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Stuttering, Adult

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Real rTMS

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

Group Type EXPERIMENTAL

Brain stimulation

Intervention Type OTHER

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

Sham rTMS

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

Group Type PLACEBO_COMPARATOR

Brain stimulation

Intervention Type OTHER

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

Interventions

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Brain stimulation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medipol University

OTHER

Sponsor Role lead

Responsible Party

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Gülkader Temiz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 9474057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32979643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19833552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26228377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28778745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30476712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32361030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15846815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15159193 (View on PubMed)

Other Identifiers

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E-10840098-202.3.02-645

Identifier Type: -

Identifier Source: org_study_id

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