Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05569902
Status:
COMPLETED
Last Update Posted:
2022-10-10
First Post:
2022-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
tACS Improves Memory in Elders With Subjective Memory Complaints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-05', 'studyFirstSubmitDate': '2022-09-24', 'studyFirstSubmitQcDate': '2022-10-03', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in performance', 'timeFrame': '25 minutes i.e., before versus after the stimulation', 'description': 'Rey auditory-verbal learning test (RAVLT)'}], 'secondaryOutcomes': [{'measure': 'Change in EEG power in theta frequency band', 'timeFrame': '30 minutes, i.e., before versus after stimulation', 'description': 'Spectral analysis measuring power in different frequency bands'}, {'measure': 'Change in phase synchronization connectivity in theta frequency band', 'timeFrame': '30 minutes, i.e., before versus after stimulation', 'description': 'Phase relations between neural signals realized by means of phase-locking values (PLV)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Episodic memory', 'medial Prefrontal Cortex', 'tACS', 'SMC'], 'conditions': ['Memory Deficits', 'tACS']}, 'descriptionModule': {'briefSummary': "Subjective memory complaints (SMC), the main cognitive component of which is event memory, is a predictor of Alzheimer's disease in elderly people. The purpose of this study was to investigate the effect of transcranial alternating current stimulation (tACS) with theta frequency (6 Hz) on the medial prefrontal cortex in the improvement of episodic memory in individuals with SMC in a double blind, randomized, and sham-controlled parallel study. Sixteen participants with SMC received either active or sham theta tACS on the medial prefrontal cortex (mPFC). EEG was recorded and Rey Auditory Verbal Learning Test (RAVLT) was administered. The aim of the current study was to see if theta tACS over the mPFC can improve event memory in individuals with SMC and thus can be considered a potential therapeutic intervention for this population or not."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 50 or older,\n* Mini Mental State Examination (MMSE) grade from 27 to 30\n* Total score of 58 or more on the Everyday Memory Questionnaire (EMQ)\n* no indications of depression and anxiety measured by Geriatric Depression Scale (GDS) and State-Trait Anxiety Inventory (STAI)\n* No sign of dementia based on Diagnostic and statistical manual of mental disorder, 5th edition (DSM-V) criteria\n\nExclusion Criteria:\n\n* History of a major psychological or neurological condition\n* History of head trauma leading to unconsciousness,\n* Presence of metal in the head\n* History of seizures\n* Serious cardiovascular disease\n* Use of medications with an impact on cognitive functions\n* Recent use of alcohol or substance abuse'}, 'identificationModule': {'nctId': 'NCT05569902', 'briefTitle': 'tACS Improves Memory in Elders With Subjective Memory Complaints', 'organization': {'class': 'OTHER', 'fullName': 'University of Tehran'}, 'officialTitle': 'Remember NIBS? tACS Improves Memory Performance in Elders With Subjective Memory Complaints', 'orgStudyIdInfo': {'id': 'tACS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tACS', 'description': 'Participants in this group received 20 minutes of active 6 Hz stimulation over the medial prefrontal cortex.', 'interventionNames': ['Device: active tACS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tACS', 'description': 'Participants in this group received 20 minutes of sham stimulation over the medial prefrontal cortex.', 'interventionNames': ['Device: sham tACS']}], 'interventions': [{'name': 'active tACS', 'type': 'DEVICE', 'description': 'transcranial alternating current stimulation is a non-invasive method of entraining specific frequency bands in the brain by applying weak intensities of electric current in a desired shape and phase to the desired brain regions.', 'armGroupLabels': ['Active tACS']}, {'name': 'sham tACS', 'type': 'DEVICE', 'description': 'transcranial alternating current stimulation is a non-invasive method of entraining specific frequency bands in the brain by applying weak intensities of electric current in a desired shape and phase to the desired brain regions.', 'armGroupLabels': ['Sham tACS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1439957131', 'city': 'Tehran', 'country': 'Iran', 'facility': 'National Brain Mapping Lab', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Reza Rostami, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tehran'}, {'name': 'Sahereh Varastegan, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tehran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tehran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'reza kazemi', 'investigatorAffiliation': 'University of Tehran'}}}}