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

January 30, 2025 updated by: Gülkader Temiz, Medipol University

Investigating the Supplementary Motor Area 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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real rTMS
Participants will be included in the real rTMS. Participants will perform speech and reading tasks before and after stimulation.
Other: Brain stimulation
Participants will be included in the real and sham rTMS. Participants will perform speech and reading tasks before and after stimulation.
Placebo Comparator: Sham rTMS
Participants will be included in the sham rTMS. Participants will perform speech and reading tasks before and after stimulation.
Other: Brain stimulation
Participants will be included in the real and sham rTMS. Participants will perform speech and reading tasks before and after stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately before the treatment (Day 1)
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.
Immediately after the treatment (Day 1)
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.
Immediately before the treatment (Day 2)
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.
Immediately after the treatment (Day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

June 15, 2025

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-202.3.02-645

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

January 2025-January 2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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