Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT02538094
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D004660', 'term': 'Encephalitis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TVannor1@jhmi.edu', 'phone': '4105023701', 'title': 'Dr. Tracy Vannorsdall', 'organization': 'Johns Hopkins University SOM'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Recruitment was not sufficient to permit planned statistical analyses.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Sham tDCS', 'description': 'Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Anodal tDCS', 'description': 'Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham tDCS', 'description': 'Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.'}, {'id': 'OG001', 'title': 'Active Anodal tDCS', 'description': 'Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.20', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '9.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at beginning and end of a 5-day treatment week', 'description': 'Change in performance on an individual cognitive test measure raw score from the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery tests (i.e. Paced Auditory Serial Addition Test scores). Change scores range from -120 to + 120. Positive change scores reflect improvement at the end of the intervention relative to baseline. Negative change scores reflect decline at the end of the intervention relative to baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham tDCS', 'description': 'Sham transcranial direct current stimulation (tDCS) is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS. Delivery of sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.'}, {'id': 'OG001', 'title': 'Active Anodal tDCS', 'description': 'Active transcranial direct current stimulation using anodal stimulation over the area of interest. Delivery of transcranial direct current stimulation for 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.40', 'spread': '8.08', 'groupId': 'OG000'}, {'value': '-15.0', 'spread': '18.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at beginning and end of a 5-day treatment week', 'description': 'Fatigue was measured via changes in self-reported fatigue on the Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) total score over the course of active and sham tDCS. Change scores range from -84 to + 84. Positive change values reflect increased symptom burden at the end of the intervention relative to baseline. Negative change scores reflect reduced symptom burden at the end of the intervention relative to baseline.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham tDCS First', 'description': 'Participants received sham tDCS first and then active anodal tDCS after washout.'}, {'id': 'FG001', 'title': 'Active Anodal tDCS First', 'description': 'Participants received active anodal tDCS first and then sham tDCS after washout.'}], 'periods': [{'title': 'Intervention 1 (5 Days Per Participant)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Intervention 2 (5 Days Per Participant)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Transcranial direct current stimulation using Anodal stimulation over the area of interest or sham stimulation using Neuro-Conn Direct Current (DC) Stimulator Plus.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.29', 'spread': '11.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Paced Auditory Serial Addition Test', 'classes': [{'categories': [{'measurements': [{'value': '76.29', 'spread': '25.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Paced Auditory Serial Addition Test (PASAT) is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. PASAT scores range from 0 to 120 with higher scores reflecting better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Multidimensional Fatigue Symptom Inventory 30-item short form score', 'classes': [{'categories': [{'measurements': [{'value': '55.43', 'spread': '23.06', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) is an instrument for assessing fatigue. MFSI-SF scores range from 0 to 84, with higher values reflecting greater fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-28', 'size': 595354, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-05T16:17', 'hasProtocol': True}, {'date': '2016-11-11', 'size': 549575, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-05T16:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2015-03-25', 'resultsFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-03', 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores', 'timeFrame': 'Assessed at beginning and end of a 5-day treatment week', 'description': 'Change in performance on an individual cognitive test measure raw score from the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery tests (i.e. Paced Auditory Serial Addition Test scores). Change scores range from -120 to + 120. Positive change scores reflect improvement at the end of the intervention relative to baseline. Negative change scores reflect decline at the end of the intervention relative to baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores', 'timeFrame': 'Assessed at beginning and end of a 5-day treatment week', 'description': 'Fatigue was measured via changes in self-reported fatigue on the Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) total score over the course of active and sham tDCS. Change scores range from -84 to + 84. Positive change values reflect increased symptom burden at the end of the intervention relative to baseline. Negative change scores reflect reduced symptom burden at the end of the intervention relative to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognitive Enhancement', 'tDCS', 'stimulation', 'MS', 'Multiple Sclerosis', 'Encephalitis'], 'conditions': ['Multiple Sclerosis', 'Encephalitis']}, 'descriptionModule': {'briefSummary': "This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities in individuals with multiple sclerosis (MS) or encephalitis. Participants will be asked to come in daily for two full weeks during which time participants will undergo cognitive testing and Magnetic Resonance Imaging (MRI) brain scans. In this research, a very weak electrical current is administered to the surface of the scalp while participants complete cognitive tasks. The investigators' aim is to find out whether tDCS will improve task performance in adults with multiple sclerosis or encephalitis.", 'detailedDescription': "Participants enrolled into this study may be asked to do the following:\n\n* Come to the investigators' testing office at the Johns Hopkins Hospital where the tDCS equipment is located for 10 study visits.\n* Grant permission for the researchers to view medical records associated with the participant's diagnosis of multiple sclerosis or encephalitis (if applicable) and general state of health.\n* Complete a questionnaire and provide a health history in order to verify eligibility to participate and be able to safely undergo the experimental procedures.\n* Complete several computerized, written, and/or aural tasks (i.e., saying words out loud) that assess different cognitive functions such as attention, memory, language, or processing speed.\n* Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) for 30 minutes.\n* Participate in several study conditions. The exact conditions and the order will be randomized. That is, the conditions and order will vary by chance (like the flip of a coin). Under some conditions, the participant might receive active stimulation (tDCS) and under other conditions, the participant might receive placebo (or sham) stimulation. Placebo stimulation is similar to active tDCS but lasts only a few seconds. However, all groups will wear the electrodes for the same length of time to prevent the participant from knowing whether participants are receiving active tDCS or sham stimulation. The study doctor and research staff will know which group the participant is in.\n* Permission to audio and/or video-tape test sessions for later scoring and observation. These tapes will not be viewed by anyone not affiliated with the study without the participant's consent.\n* Have structural, resting-state and functional Magnetic Resonance Imaging scans as a part of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis or encephalitis\n* Over the age of 18\n\nExclusion Criteria:\n\n* A diagnosis of schizophrenia bipolar disorder\n* Beck Depression Inventory-II scores over 20\n* Mini Mental Exam below 24\n* Any uncontrolled seizure disorder\n* Any implanted metal device or hearing aids\n* Use of medication shown to interact with tDCS effectiveness'}, 'identificationModule': {'nctId': 'NCT02538094', 'briefTitle': 'tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Transcranial Direct Current Stimulation and Cognition in Adults With Multiple Sclerosis or Encephalitis', 'orgStudyIdInfo': {'id': 'IRB00033581'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Stimulation First', 'description': 'Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS first and then Anodal Stimulation second.', 'interventionNames': ['Device: Sham Transcranial direct current stimulation', 'Device: Anodal Transcranial direct current stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Anodal Stimulation First', 'description': 'Transcranial direct current stimulation using Anodal stimulation first over the area of interest and then Sham Stimulation second.', 'interventionNames': ['Device: Sham Transcranial direct current stimulation', 'Device: Anodal Transcranial direct current stimulation']}], 'interventions': [{'name': 'Sham Transcranial direct current stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus.', 'armGroupLabels': ['Anodal Stimulation First', 'Sham Stimulation First']}, {'name': 'Anodal Transcranial direct current stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Delivery of transcranial direct current stimulation for 30 minutes.', 'armGroupLabels': ['Anodal Stimulation First', 'Sham Stimulation First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins East Baltimore Campus; Medical Psychiatry department', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Tracy Vannorsdall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}