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Набор по приглашению NCT06809387

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

Без фазы С лечением Stuttering, Adult

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Brain stimulation.
Кому может быть актуально
Состояния в реестре: Stuttering, Adult. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

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

Публикации

  • 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

Идентификаторы

NCT: NCT06809387 · E-10840098-202.3.02-645

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗