Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT04961112
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2021-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All study staff are blinded to active and sham brain stimulation devices until the completion of data collection.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Task switching', 'timeFrame': '68 weeks', 'description': 'Switch cost (mean switch reaction time- mean stay reaction time)'}, {'measure': 'Working memory (N-back)', 'timeFrame': '68 weeks', 'description': '2-back condition mean accuracy'}, {'measure': 'Inhibition (Stroop)', 'timeFrame': '68 weeks', 'description': 'Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)'}, {'measure': 'Processing speed (Simple reaction time task)', 'timeFrame': '68 weeks', 'description': 'Mean reaction time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cranial electrotherapy stimulation', 'Executive functioning', 'Induced Anxiety', 'Cognition', 'Threat of shock', 'Heart rate variability'], 'conditions': ['Anxiety', 'Cognitive Deficit']}, 'descriptionModule': {'briefSummary': 'This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18-28 years old\n\nExclusion Criteria:\n\n* History of diagnosis with a neurological or psychiatric disorder.'}, 'identificationModule': {'nctId': 'NCT04961112', 'briefTitle': 'Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits', 'organization': {'class': 'OTHER', 'fullName': 'Tufts University'}, 'officialTitle': 'Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits', 'orgStudyIdInfo': {'id': '1908026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental - Induced Anxiety', 'description': 'Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments.\n\nParticipants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).', 'interventionNames': ['Device: Cranial Electrotherapy Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental - No Induced Anxiety', 'description': 'Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments.\n\nParticipants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).', 'interventionNames': ['Device: Cranial Electrotherapy Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham - Induced Anxiety', 'description': 'Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments.\n\nParticipants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).', 'interventionNames': ['Device: Sham Cranial Electrotherapy Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham - No Induced Anxiety', 'description': 'Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments.\n\nParticipants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time).', 'interventionNames': ['Device: Sham Cranial Electrotherapy Stimulation']}], 'interventions': [{'name': 'Cranial Electrotherapy Stimulation', 'type': 'DEVICE', 'otherNames': ['Transcranial Pulsed Current Stimulation', 'Cranial Electrical Stimulation'], 'description': 'Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).', 'armGroupLabels': ['Experimental - Induced Anxiety', 'Experimental - No Induced Anxiety']}, {'name': 'Sham Cranial Electrotherapy Stimulation', 'type': 'DEVICE', 'description': 'Participants will receive sham stimulation on one of two separate visits (within-subjects).', 'armGroupLabels': ['Sham - Induced Anxiety', 'Sham - No Induced Anxiety']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02155', 'city': 'Medford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts University', 'geoPoint': {'lat': 42.41843, 'lon': -71.10616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nathan Ward', 'investigatorAffiliation': 'Tufts University'}}}}