Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT04276805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2020-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in working memory and processing speed contributors', 'timeFrame': 'Baseline to 2 weeks', 'description': 'The Posit Science BrainHQ'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. The present proposal is designed to evaluate the pairing of cognitive training with a non-invasive neurostimulation technology that has shown promise in both increasing neuroplasticity and in enhancing cognitive performance, transcutaneous vagal nerve stimulation (tVNS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals willing to commit to study requirements\n\nExclusion Criteria:\n\n* Neurological disorders to include traumatic brain injury.\n* Evidence of dementia .\n* Major psychiatric illness\n* Unstable and chronic medical conditions.\n* MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).\n* Physical impairment precluding motor response or lying still or walking\n* Hearing or vision deficits that will not allow for completion of assessments'}, 'identificationModule': {'nctId': 'NCT04276805', 'briefTitle': 'Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Non-invasive Nerve Stimulation and Cognitive Training to Improve Cognitive Performance in Healthy Older Adults', 'orgStudyIdInfo': {'id': 'IRB201902991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'tVNS group', 'description': 'Participants will undergo cognitive training with tVNS', 'interventionNames': ['Device: Transcutaneous vagal nerve stimulation (tVNS)', 'Behavioral: cognitive training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Participants will undergo cognitive training with earlobe sham', 'interventionNames': ['Behavioral: cognitive training']}], 'interventions': [{'name': 'Transcutaneous vagal nerve stimulation (tVNS)', 'type': 'DEVICE', 'description': 'a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.', 'armGroupLabels': ['tVNS group']}, {'name': 'cognitive training', 'type': 'BEHAVIORAL', 'description': "A program of regular mental activities purported to maintain or improve one's cognitive abilities.", 'armGroupLabels': ['Sham group', 'tVNS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'John Williamson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Arizona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}