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Using Transcranial Magnetic Stimulation to Treat Stuttering

K

Kansas State University

Status

Enrolling

Conditions

Stuttering, Adult

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07389694
KPelczarski

Details and patient eligibility

About

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

Full 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.

Enrollment

2 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Transcranial Magnetic Stimulation to treat stuttering
Experimental group
Description:
There is only one arm to this study. All participants will receive 10 days of Transcranial Magnetic Stimulation to specific cortical speech and motor areas.
Treatment:
Device: Transcranial Magnetic Stimulation

Trial contacts and locations

1

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Central trial contact

Julio Hernandez Pavon, Ph.D., DSc; Kristin Pelczarski, Ph.D.

Data sourced from clinicaltrials.gov

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