Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT05286151
Status:
RECRUITING
Last Update Posted:
2025-10-23
First Post:
2022-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Network Connectivity and Temporal Processing in Adolescents Who Stutter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013342', 'term': 'Stuttering'}, {'id': 'D013064', 'term': 'Speech Disorders'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Rhythm discrimination (d')", 'timeFrame': 'Year 1', 'description': "Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different. Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR))."}, {'measure': "Rhythm discrimination (d')", 'timeFrame': 'Year 2', 'description': "Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different. Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR))."}, {'measure': "Rhythm discrimination (d')", 'timeFrame': 'Year 3', 'description': "Performance on the rhythm discrimination task will be assessed using a signal detection analysis to distinguish between participants' ability to discriminate same and different rhythms from any general tendency to respond same or different. Hit rates (HRs) and false alarm rates (FARs) will be obtained to calculate d' (a measure of sensitivity; determined by z(HR) - z(FAR))."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhythm', 'Temporal processing', 'Healthy children', 'Speech disorders', 'Timing'], 'conditions': ['Stuttering, Childhood', 'Stuttering']}, 'descriptionModule': {'briefSummary': 'The specific purpose of this clinical trial is to compare performance on rhythm perception and production tasks between children who stutter and children who do not stutter. The overall project also aims to investigate how performance on rhythm tasks may be related to brain activity (non-clinical trial).', 'detailedDescription': 'Participants in the clinical trial portion of this study will complete rhythm discrimination and finger tapping experiments once a year for 3 years. The study team will compare performance between groups. Participants will also participate in the non-trial portion of the project that includes having magnetic resonance imaging (MRI) each year for 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Children who stutter:\n\n* English as primary language\n* Current or past stuttering diagnosis\n\nInclusion Criteria Children who do not stutter:\n\n* English as primary language\n\nExclusion Criteria Children who stutter:\n\n* Diagnosed/under treatment for any neurological or psychiatric conditions\n* Head trauma with loss of consciousness\n* Major medical illness\n* Hearing loss- Language/motor delay (below -2 standard deviations on standardized assessments)\n* Face, motor, or reflex abnormalities\n\nExclusion Criteria Children who do not stutter:\n\n* Personal or family history of stuttering\n* Diagnosed/under treatment for any neurological or psychiatric conditions\n* Head trauma with loss of consciousness\n* Major medical illness\n* Hearing loss\n* Language/motor delay (below -2 standard deviations on standardized assessments\n* Face, motor, or reflex abnormalities'}, 'identificationModule': {'nctId': 'NCT05286151', 'briefTitle': 'Network Connectivity and Temporal Processing in Adolescents Who Stutter', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Subcortical Network Connectivity and Temporal Processing in Children With Persistent and Recovered Stuttering', 'orgStudyIdInfo': {'id': 'HUM00196133'}, 'secondaryIdInfos': [{'id': '2R01DC011277', 'link': 'https://reporter.nih.gov/quickSearch/2R01DC011277', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children who stutter', 'description': 'Children who stutter', 'interventionNames': ['Behavioral: Rhythm discrimination']}, {'type': 'EXPERIMENTAL', 'label': 'Children who do not stutter', 'description': 'Children who do not stutter', 'interventionNames': ['Behavioral: Rhythm discrimination']}], 'interventions': [{'name': 'Rhythm discrimination', 'type': 'BEHAVIORAL', 'description': 'Participants will complete a rhythm discrimination task once per year for 3 years.', 'armGroupLabels': ['Children who do not stutter', 'Children who stutter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Soo-Eun Chang, PhD', 'role': 'CONTACT', 'email': 'sooeunc@umich.edu', 'phone': '734-232-0300'}, {'name': 'Soo-Eun Chang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Soo-Eun Chang, PhD', 'role': 'CONTACT', 'email': 'sooeunc@umich.edu', 'phone': '734-232-0300'}, {'name': 'Emily Garnett, PhD', 'role': 'CONTACT', 'email': 'emilyog@umich.edu', 'phone': '734-232-3371'}], 'overallOfficials': [{'name': 'Soo-Eun Chang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Soo-Eun Chang', 'investigatorAffiliation': 'University of Michigan'}}}}