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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013342', 'term': 'Stuttering'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Repeated measures, single subject design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in functional connectivity with resting-state electroencephalography (rs-EEG)', 'timeFrame': 'Baseline, immediately post-treatment, and one week after post-treatment.', 'description': 'A seed-based functional connectivity analysis will be carried out between the two stimulated brain areas. To assess the changes in effective connectivity, the investigators will compare the seed-based connectivity values across sessions.'}, {'measure': 'Changes in behavioral measures of stuttering and phonological processing.', 'timeFrame': 'Baseline, immediately post-treatment, and one week after post-treatment.', 'description': 'To assess functional changes as a result of rTMS treatment, comparison of eye tracking measurements of duration, dwell time, and number of fixations of eye movements while completing speech and language-based tasks are compared across sessions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['stuttering', 'noninvasive treatment', 'transcranial magnetic stimulation', 'eye tracking', 'EEG'], 'conditions': ['Stuttering, Adult']}, 'referencesModule': {'references': [{'pmid': '17565358', 'type': 'BACKGROUND', 'citation': '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': '30954150', 'type': 'BACKGROUND', 'citation': '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': '36828303', 'type': 'BACKGROUND', 'citation': '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(2):567-593. doi: 10.1016/j.brs.2023.02.009. Epub 2023 Feb 23.'}, {'pmid': '29976115', 'type': 'BACKGROUND', 'citation': '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': '27280891', 'type': 'BACKGROUND', 'citation': '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': '24759190', 'type': 'BACKGROUND', 'citation': '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': '25680736', 'type': 'BACKGROUND', 'citation': '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': '16814376', 'type': 'BACKGROUND', 'citation': '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': '18442810', 'type': 'BACKGROUND', 'citation': 'Strand F, Forssberg H, Klingberg T, Norrelgen F. Phonological working memory with auditory presentation of pseudo-words -- an event related fMRI Study. Brain Res. 2008 May 30;1212:48-54. doi: 10.1016/j.brainres.2008.02.097. Epub 2008 Mar 18.'}, {'pmid': '28631005', 'type': 'BACKGROUND', 'citation': 'Perrachione TK, Ghosh SS, Ostrovskaya I, Gabrieli JDE, Kovelman I. Phonological Working Memory for Words and Nonwords in Cerebral Cortex. J Speech Lang Hear Res. 2017 Jul 12;60(7):1959-1979. doi: 10.1044/2017_JSLHR-L-15-0446.'}, {'pmid': '29228195', 'type': 'BACKGROUND', 'citation': 'Neef NE, Anwander A, Butfering C, Schmidt-Samoa C, Friederici AD, Paulus W, Sommer M. Structural connectivity of right frontal hyperactive areas scales with stuttering severity. Brain. 2018 Jan 1;141(1):191-204. doi: 10.1093/brain/awx316.'}, {'pmid': '25595146', 'type': 'BACKGROUND', 'citation': 'Neef NE, Hoang TN, Neef A, Paulus W, Sommer M. Speech dynamics are coded in the left motor cortex in fluent speakers but not in adults who stutter. Brain. 2015 Mar;138(Pt 3):712-25. doi: 10.1093/brain/awu390. Epub 2015 Jan 15.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Will there be changes in the brains of people who stutter because of the treatment?\n* Will any changes in the brain result in less stuttering?\n\nParticipants will:\n\n* Visit the lab 3 times before treatment for tests\n* Complete 10 rTMS sessions\n* Visit the lab 2 times after treatment for tests', 'detailedDescription': '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.\n\nMRI/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).\n\nNeuronavigation: 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.\n\nThree pre-treatment and 2 post-treatment sessions will each obtain data from the following measurements:\n\n* rs-EEG: rs-EEG responses will be recorded with eyes open for 5 minutes using a 64-channel EEG system.\n* Eye tracker: eye gaze fixations, dwell time, saccades, and gaze durations will be recorded while the participant completes several behavioral phonological memory tasks.\n* Spontaneous speech sample will be obtained to determine percent syllables stuttered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age from 18 to 65 years\n* Self-identifies as a person who currently stutters\n* Right-handed or left-handed\n* Normal hearing and (corrected) vision\n* Able to understand and give informed consent\n* Monolingual English speaker\n\nExclusion Criteria:\n\n* Cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps\n* Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye\n* Facial tattoos\n* Not having medical insurance\n* Surgical clips in the head or previous neurosurgery\n* Any magnetic particles in the body\n* Cochlear implants\n* Prosthetic heart valves\n* Epilepsy or any other type of seizure history\n* History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)\n* Known structural brain lesions\n* Pre-existing speech, language, or neurological disorder (except for stuttering)\n* Significant other disease (heart disease, malignant tumors, mental disorders)\n* Significant claustrophobia; Ménière's disease\n* Women who are trying to get pregnant and sexually active women (of reproductive age) not on a reliable contraceptive\n* Pregnancy, breastfeeding\n* Medications increasing the risk for seizures\n* Non-prescribed drug use\n* Use of recreational drugs such as medical marijuana\n* Failure to perform the behavioral tasks or neuropsychological evaluation tests\n* Prisoners"}, 'identificationModule': {'nctId': 'NCT07389694', 'briefTitle': 'Using Transcranial Magnetic Stimulation to Treat Stuttering', 'organization': {'class': 'OTHER', 'fullName': 'Kansas State University'}, 'officialTitle': 'Modulating Bilateral Cortical Activation In Adults Who Stutter: A Pilot Study', 'orgStudyIdInfo': {'id': 'KPelczarski'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Magnetic Stimulation to treat stuttering', '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.', 'interventionNames': ['Device: Transcranial Magnetic Stimulation']}], 'interventions': [{'name': 'Transcranial Magnetic Stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Transcranial Magnetic Stimulation to treat stuttering']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66506-7500', 'city': 'Manhattan', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julio Hernandez Pavon, Ph.D., D.Sc.', 'role': 'CONTACT', 'email': 'juliohpavon@ksu.edu', 'phone': '785-532-0805'}, {'name': 'Julio Hernandez Pavon, Ph.D., D.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kristin Pelczarski, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bluemont Hall, Department of Psychological Sciences, Kansas State University', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}], 'centralContacts': [{'name': 'Kristin Pelczarski, Ph.D.', 'role': 'CONTACT', 'email': 'kpelczar@ksu.edu', 'phone': '785-532-6879'}, {'name': 'Julio Hernandez Pavon, Ph.D., DSc', 'role': 'CONTACT', 'email': 'juliohpavon@ksu.edu'}], 'overallOfficials': [{'name': 'Kristin Pelczarski, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas State University'}, {'name': 'Julio Hernandez Pavon, Ph.D., DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD used in the results publication with be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kristin Pelczarski', 'investigatorAffiliation': 'Kansas State University'}}}}