Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-05 @ 2:36 AM
Study NCT ID:
NCT06127550
Status:
SUSPENDED
Last Update Posted:
2025-12-11
First Post:
2023-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
taVNS for Letter Learning in Dyslexia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004410', 'term': 'Dyslexia'}], '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': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'All participants will be told they are receiving active stimulation at a custom current level that may or may not be detectable to them. Half of the participants (randomly assigned) will not receive stimulation.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to either active stimulation or sham stimulation groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'Waiting on funding to support study', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'fMRI', 'timeFrame': '6 weeks', 'description': "Strength of the brain's response to learned letters in the visual word form area"}], 'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '4 weeks', 'description': 'Frequency and severity of adverse events will be monitored and evaluated for severity and impact on attrition.'}, {'measure': 'Compliance', 'timeFrame': '4 weeks', 'description': 'Percentage of the population that remains engaged in the study and completes all stimulation sessions.'}], 'secondaryOutcomes': [{'measure': 'Letter ID', 'timeFrame': '6 weeks', 'description': 'Percent correct of learned letter-sound relationships'}, {'measure': 'Decoding', 'timeFrame': '6 weeks', 'description': 'Percent correct of pseudowords read in 45 seconds'}, {'measure': 'Automaticity', 'timeFrame': '6 weeks', 'description': 'This measure is based on a standardized measure for rapid letter naming in English (CTOPP-Rapid Automatized Naming) in which the participant is shown a grid of many letters in Hebrew and are asked to read the grid as quickly and accurately as possible while being timed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dyslexia']}, 'descriptionModule': {'briefSummary': "This is a pilot study to establish feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) for improving letter-learning in adolescents with dyslexia. The main goals of the study are to 1) evaluate whether children in this age range will tolerate low level stimulation over the course of multiple sessions, 2) determine whether low level taVNS improves novel letter learning in dyslexia, and 3) evaluate the effect of low level taVNS on the brain's response to letters. Participants will complete fMRI before training, immediately after training, and a few weeks after training ends. Training will consist of six 30-minute lessons during which participants will learn novel letter-sound relationships while receiving either active or sham taVNS. Researchers will compare stimulation conditions to determine effect of this device on learning and neural plasticity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal non-verbal IQ\n* Reading scores above 90 on four single word reading measures (typical reader) OR reading scores below 90 on two or more single word reading measures (dyslexia) with or without ADHD\n\nExclusion Criteria:\n\n* Neurological diagnoses (e.g., autism, epilepsy, etc.)\n* Medications other than those prescribed for ADHD\n* Nonverbal IQ below 80'}, 'identificationModule': {'nctId': 'NCT06127550', 'briefTitle': 'taVNS for Letter Learning in Dyslexia', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Effect of Non-invasive Vagus Nerve Stimulation on Letter Learning in Dyslexia', 'orgStudyIdInfo': {'id': 'IRB202301883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active taVNS', 'description': 'Participants will receive custom current at 5 Hz to the left auricular branch of the vagus nerve while learning new letter-sound relationships.', 'interventionNames': ['Device: active taVNS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham taVNS', 'description': 'Participants will undergo current thresholding but device will be turned off without their knowledge during the training.', 'interventionNames': ['Device: sham taVNS']}], 'interventions': [{'name': 'active taVNS', 'type': 'DEVICE', 'description': 'low level stimulation to the auricular branch of the vagus nerve', 'armGroupLabels': ['Active taVNS']}, {'name': 'sham taVNS', 'type': 'DEVICE', 'description': 'device placed with no current administered', 'armGroupLabels': ['Sham taVNS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}