Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:27 AM
Study NCT ID:
NCT07389694
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Transcranial Magnetic Stimulation to Treat Stuttering
Sponsor:
Kansas State University
Organization:
Study Overview
Official Title:
Modulating Bilateral Cortical Activation In Adults Who Stutter: A Pilot Study
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if repeated transcranial magnetic stimuli (rTMS) can treat stuttering in adults. The main questions it aims to answer are:
* Will there be changes in the brains of people who stutter because of the treatment?
* Will any changes in the brain result in less stuttering?
Participants will:
* Visit the lab 3 times before treatment for tests
* Complete 10 rTMS sessions
* Visit the lab 2 times after treatment for tests
* Will there be changes in the brains of people who stutter because of the treatment?
* Will any changes in the brain result in less stuttering?
Participants will:
* Visit the lab 3 times before treatment for tests
* Complete 10 rTMS sessions
* Visit the lab 2 times after treatment for tests
Detailed Description:
Measures must be obtained to in preparation for TMS treatment. Structural MRI and resting-state functional MRI (rsfMRI) recordings will be obtained from the participant, and they will undergo a neuronavigational session to determine best placement for the electrodes.
MRI/rsfMRI recordings: The structural MRIs will be obtained and used for TMS neuronavigation. Resting-state functional MRI will be recorded for 8 min with the eyes open. rTMS will be delivered at 10 Hz for 10 min with a stimulation intensity of 120% of the resting motor threshold (rMT).
Neuronavigation: The TMS coil will be navigated with a neuronavigation system using the individual MRIs. rTMS targets: rTMS will be delivered to the left inferior frontal gyrus (IFG). We will use the neuronavigation system to identify the IFG.
Three pre-treatment and 2 post-treatment sessions will each obtain data from the following measurements:
* rs-EEG: rs-EEG responses will be recorded with eyes open for 5 minutes using a 64-channel EEG system.
* Eye tracker: eye gaze fixations, dwell time, saccades, and gaze durations will be recorded while the participant completes several behavioral phonological memory tasks.
* Spontaneous speech sample will be obtained to determine percent syllables stuttered.
MRI/rsfMRI recordings: The structural MRIs will be obtained and used for TMS neuronavigation. Resting-state functional MRI will be recorded for 8 min with the eyes open. rTMS will be delivered at 10 Hz for 10 min with a stimulation intensity of 120% of the resting motor threshold (rMT).
Neuronavigation: The TMS coil will be navigated with a neuronavigation system using the individual MRIs. rTMS targets: rTMS will be delivered to the left inferior frontal gyrus (IFG). We will use the neuronavigation system to identify the IFG.
Three pre-treatment and 2 post-treatment sessions will each obtain data from the following measurements:
* rs-EEG: rs-EEG responses will be recorded with eyes open for 5 minutes using a 64-channel EEG system.
* Eye tracker: eye gaze fixations, dwell time, saccades, and gaze durations will be recorded while the participant completes several behavioral phonological memory tasks.
* Spontaneous speech sample will be obtained to determine percent syllables stuttered.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: