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Enrolling by Invitation

NCT Number: NCT06809387

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain stimulation

Other

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

Primary outcomes

  1. Severity of stuttering in speech and reading Day 1 (pre-treatment)

    Time frame: Immediately before the treatment (Day 1)

    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.

  2. Severity of stuttering in speech and reading Day 1 (post-treatment)

    Time frame: Immediately after the treatment (Day 1)

    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.

  3. Severity of stuttering in speech and reading Day 2 (pre-treatment)

    Time frame: Immediately before the treatment (Day 2)

    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.

  4. Severity of stuttering in speech and reading Day 2 (post-treatment)

    Time frame: Immediately after the treatment (Day 2)

    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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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