Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-28 @ 4:01 PM
Study NCT ID:
NCT06375395
Status:
UNKNOWN
Last Update Posted:
2024-08-07
First Post:
2024-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Boosting The Intervention Effect of Negative Memory Through tACS Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2024-01-01', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative memory retention', 'timeFrame': 'Day 5', 'description': 'The intervention could disrupt retention of associative negative memory and degree of detail of the negative memories in last A-C paired associate memory test.'}], 'secondaryOutcomes': [{'measure': 'The negative emotional intensity of negative memory', 'timeFrame': 'Day 5', 'description': 'The negative memories emotional relief as assesses by the Self-Assessment Manikin (SAM) Measure Scales in last A-C paired associate memory test.\n\nThis measure is constant retrieval practice of neutral memories (A-Cneu) will result in negative memories emotional relief (A-Bneg) compared to the restudy condition.'}, {'measure': 'The retention of associated neutral memories as assesses by the proportions of responses of correctly choosing picture category of B picture (A-Bneu) in last A-B paired associate memory test', 'timeFrame': 'Day 5', 'description': 'This measure is continuous rumination of negative memories (A-Cneg) will increase the strength of associated memories (A-Bneu).'}, {'measure': 'The negative emotional intensity of neutral memory', 'timeFrame': 'Day 5', 'description': 'The emotion-diffusing effects of negative memory rumination as assesses by negative emotional intensity of neutral memories (A-Bneu),which is meature by the Self-Assessment Manikin (SAM) Measure Scales. The negative emotional intensity of neutral memories are more negative with constant retrieval practice of negative memories (A-Cneg) that is the emotion-diffusing effects of negative memory rumination.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['seizure', 'transcranial alternating current stimulation', 'neuromodulation', 'negative memory', 'neural mechanisms', 'retrieval practice', 'working memory'], 'conditions': ['Seizures']}, 'descriptionModule': {'briefSummary': "The objectives of this study include: 1) investigating the impact of negative memory substitution on an individual's other intellectual memories (i.e., neutral memories) and the underlying neurocognitive mechanisms; 2) investigating the memory enhancement effect resulting from retrieval practice associated with memory substitution intervention along with an examination of the neurocognitive mechanisms responsible for this enhancement.", 'detailedDescription': 'This study will adopt two memory updating strategies: retrieval practice and reactivation.\n\nA 5-day memory updating experimental paradigm is used.\n\n1. On the first day, the old memory A-B linkage is learned, where A represents a neutral word and B is either neutral or negative pictures (half of each, randomly scrambled).\n2. On the second day, the old memory A-B association is consolidated again, and after a 15-minute break, the new memory A-C association is learned, where A is still the word A used in the old memory A-B association on the first day, and C is the new neutral and negative pictures (half of each, randomly scrambled, and with inconsistent categories of C and B in each pair of AC and AB). Immediately following this, the new memories of the A-C conjunctions are updated using both Retrieval practice and Restudy (control condition) memory strategies.\n3. A-C is extracted/learned using both Retrieval practice and Restudy memory strategies on both day 3 and day 4.\n4. On the fifth day, memory tests for associative memory strength, gist and detail memory, as well as emotional valence and strength are performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility\n\nInclusion Criteria:\n\n1. 14-60 years old, male or female, Han Chinese;\n2. Drug-resistant epilepsy;\n3. Required surgical implantation of SEEG electrodes.\n\nExclusion Criteria:\n\n1. Progressive encephalopathy or progressive structural damage in the central nervous system;\n2. Significant heart, liver, renal insufficiency, and other medical diseases;\n3. Severe side effects from taking antiepileptic drugs at the time of enrollment and not inappropriate for SEEG;\n4. Significant intellectual disability;\n5. A history of alcohol and drug abuse;\n6. Any contraindication to MRI.'}, 'identificationModule': {'nctId': 'NCT06375395', 'briefTitle': 'Boosting The Intervention Effect of Negative Memory Through tACS Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Research on Improving the Intervention Effect of Negative Memory Through tACS Enhanced Memory Technology', 'orgStudyIdInfo': {'id': 'Memory Updating Tasks'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tACS', 'description': 'Those who participate in the treatment group will receive tACS, which lasts for 40 minutes per day on 3 consecutive days.', 'interventionNames': ['Device: Active tACS Device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham tACS', 'description': 'Those who participate in the control group will receive sham tACS, which lasts for 40 minutes per day on 3 consecutive days.', 'interventionNames': ['Device: Sham tACS Device']}], 'interventions': [{'name': 'Active tACS Device', 'type': 'DEVICE', 'description': 'Transcranial Alternating Current Stimulation', 'armGroupLabels': ['Active tACS']}, {'name': 'Sham tACS Device', 'type': 'DEVICE', 'description': 'Placebo Device that simulates active tACS treatment', 'armGroupLabels': ['Sham tACS']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hongxing Wang, MD & PhD', 'role': 'CONTACT', 'email': 'hxwang8888@126.com', 'phone': '01083198513'}], 'overallOfficials': [{'name': 'Guoguang Zhao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Normal University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}