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Recruiting NCT07389694

Using Transcranial Magnetic Stimulation to Treat Stuttering

No phase Interventional Stuttering, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Stuttering, Adult. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Modulating Bilateral Cortical Activation In Adults Who Stutter: A Pilot Study

Overview

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

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.

Interventions

  • Device Transcranial Magnetic Stimulation
    This study uses Transcranial Magnetic Stimulation (TMS) applied to specific speech and motor areas of the brain to stimulate cortical areas that experience reduced activations during left-hemisphere dominant tasks in people who stutter.

Primary outcome measures

  • Changes in functional connectivity with resting-state electroencephalography (rs-EEG) [Time frame: Baseline, immediately post-treatment, and one week after post-treatment.]
  • Changes in behavioral measures of stuttering and phonological processing. [Time frame: Baseline, immediately post-treatment, and one week after post-treatment.]

Eligibility criteria

Inclusion criteria

  • Age from 18 to 65 years
  • Self-identifies as a person who currently stutters
  • Right-handed or left-handed
  • Normal hearing and (corrected) vision
  • Able to understand and give informed consent
  • Monolingual English speaker

Exclusion criteria

  • Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps
  • Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
  • Facial tattoos
  • Not having medical insurance
  • Surgical clips in the head or previous neurosurgery
  • Any magnetic particles in the body
  • Cochlear implants
  • Prosthetic heart valves
  • Epilepsy or any other type of seizure history
  • History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
  • Known structural brain lesions
  • Pre-existing speech, language, or neurological disorder (except for stuttering)
  • Significant other disease (heart disease, malignant tumors, mental disorders)
  • Significant claustrophobia; Ménière's disease
  • Women who are trying to get pregnant and sexually active women (of reproductive age) not on a reliable contraceptive
  • Pregnancy, breastfeeding
  • Medications increasing the risk for seizures
  • Non-prescribed drug use
  • Use of recreational drugs such as medical marijuana
  • Failure to perform the behavioral tasks or neuropsychological evaluation tests
  • Prisoners

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Bluemont Hall, Department of Psychological Sciences, Kansas State University — Manhattan

Publications

  • Ridding MC, Rothwell JC. Is there a future for therapeutic use of transcranial magnetic stimulation? Nat Rev Neurosci. 2007 Jul;8(7):559-67. doi: 10.1038/nrn2169. PMID 17565358
  • Hernandez-Pavon JC, Harvey RL. Noninvasive Transcranial Magnetic Brain Stimulation in Stroke. Phys Med Rehabil Clin N Am. 2019 May;30(2):319-335. doi: 10.1016/j.pmr.2018.12.010. Epub 2019 Feb 21. PMID 30954150
  • Hernandez-Pavon JC, Veniero D, Bergmann TO, Belardinelli P, Bortoletto M, Casarotto S, Casula EP, Farzan F, Fecchio M, Julkunen P, Kallioniemi E, Lioumis P, Metsomaa J, Miniussi C, Mutanen TP, Rocchi L, Rogasch NC, Shafi MM, Siebner HR, Thut G, Zrenner C, Ziemann U, Ilmoniemi RJ. TMS combined with EEG: Recommendations and open issues for data collection and analysis. Brain Stimul. 2023 Mar-Apr;16( PMID 36828303
  • Pelczarski KM, Tendera A, Dye M, Loucks TM. Delayed Phonological Encoding in Stuttering: Evidence from Eye Tracking. Lang Speech. 2019 Sep;62(3):475-493. doi: 10.1177/0023830918785203. Epub 2018 Jul 6. PMID 29976115
  • Pelczarski KM, Yaruss JS. Phonological memory in young children who stutter. J Commun Disord. 2016 Jul-Aug;62:54-66. doi: 10.1016/j.jcomdis.2016.05.006. Epub 2016 May 17. PMID 27280891
  • Pelczarski KM, Yaruss JS. Phonological encoding of young children who stutter. J Fluency Disord. 2014 Mar;39:12-24. doi: 10.1016/j.jfludis.2013.10.003. Epub 2013 Nov 20. PMID 24759190
  • Byrd CT, McGill M, Usler E. Nonword repetition and phoneme elision in adults who do and do not stutter: Vocal versus nonvocal performance differences. J Fluency Disord. 2015 Jun;44:17-31. doi: 10.1016/j.jfludis.2015.01.004. Epub 2015 Jan 24. PMID 25680736
  • Anderson JD, Wagovich SA, Hall NE. Nonword repetition skills in young children who do and do not stutter. J Fluency Disord. 2006;31(3):177-99. doi: 10.1016/j.jfludis.2006.05.001. Epub 2006 Jun 30. PMID 16814376

Identifiers

NCT: NCT07389694 · KPelczarski

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗