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

NCT06809387 | Enrolling By Invitation

• 1 other identifier: E-10840098-202.3.02-645
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Stuttering, Adult

Keywords

rTMS; stuttering; SMA

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Immediately after the treatment (Day 2)

Study Arms (2)

Real rTMS

EXPERIMENTAL

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

Other: Brain stimulation

Sham rTMS

PLACEBO COMPARATOR

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

Other: Brain stimulation

Interventions

Brain stimulation OTHER

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

Real rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 15159193 BACKGROUND

MeSH Terms

Conditions

Stuttering

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: February 5, 2025
• Study Start: January 1, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: January 2025-January 2026

Locations

TU (1)