Investigating the SMA's Role in Speech and Reading Fluency in PWS with RTMS

Not Applicable

• Conditions: Stuttering, Adult

• Registration Number: NCT06809387
• Lead Sponsor: Medipol University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Trial Locations

Locations (1)

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