Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-02-11 @ 7:27 AM
Study NCT ID:
NCT03658668
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2018-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Matthew.Lustberg@nyulangone.org', 'phone': '929 445 5090', 'title': 'Mathew Lustberg, MA', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 days', 'description': 'Standard questionnaire.', 'eventGroups': [{'id': 'EG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tingling at the electrode site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching at the electrode site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Warmth Sensation at the electrode site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Gait Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'OG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': 'Measured by a 10 meter walk test using wearable inertial sensors', 'unitOfMeasure': 'meters/second (m/s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Stride Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'OG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': 'Measured by a 10 meter walk test using wearable inertial sensors', 'unitOfMeasure': 'meters (m)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of tDCS Sessions Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'OG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Final Treatment Session (Up to Week 3)', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in 12-item Multiple Sclerosis Walking Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'OG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': '12-item questionnaire assessing how multiple sclerosis (MS) affects walking abilities. Items are ranked on a scale from 1 (not at all) to 5 (extremely). The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater impact of MS on walking abilities.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change 21-item Modified Fatigue Impact Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'OG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.4', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': '21-item questionnaire assessing how fatigue may affect a person. Items are ranked on a scale from 0 (never) to 4 (almost always). The total score is the sum of responses and ranges from 0 to 84; scores indicate greater impact of fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'FG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Time Commitment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active tDCS+PA', 'description': 'active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'BG001', 'title': 'Sham tDCS+PA', 'description': 'sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.\n\nPhysical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '55', 'spread': '7.55', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-09', 'size': 1263367, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-30T11:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2018-08-14', 'resultsFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2018-08-31', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-25', 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gait Velocity', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': 'Measured by a 10 meter walk test using wearable inertial sensors'}, {'measure': 'Change in Stride Length', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': 'Measured by a 10 meter walk test using wearable inertial sensors'}], 'secondaryOutcomes': [{'measure': 'Percent of tDCS Sessions Completed', 'timeFrame': 'End of Final Treatment Session (Up to Week 3)'}, {'measure': 'Change in 12-item Multiple Sclerosis Walking Scale Score', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': '12-item questionnaire assessing how multiple sclerosis (MS) affects walking abilities. Items are ranked on a scale from 1 (not at all) to 5 (extremely). The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater impact of MS on walking abilities.'}, {'measure': 'Change 21-item Modified Fatigue Impact Scale Score', 'timeFrame': 'Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)', 'description': '21-item questionnaire assessing how fatigue may affect a person. Items are ranked on a scale from 0 (never) to 4 (almost always). The total score is the sum of responses and ranges from 0 to 84; scores indicate greater impact of fatigue.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '32431658', 'type': 'DERIVED', 'citation': 'Pilloni G, Choi C, Coghe G, Cocco E, Krupp LB, Pau M, Charvet LE. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise. Front Neurol. 2020 May 5;11:310. doi: 10.3389/fneur.2020.00310. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.\n\nThe subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).\n\nPortions of this study may be completed remotely.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable and continuous access to internet service at home\n* Adequate home facilities (enough space, access to quiet and distraction free area)\n* Definite MS diagnosis, subtype relapsing-remitting (RR-MS)\n* Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations\n* Clinically stable and stable on treatment with disease modifying agents at least from 6 months\n* Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance\n* Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders\n* Able to use study equipment\n* Able to commit 10 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits\n* Able to understand the informed consent process and provide consent to participate in the study\n\nExclusion Criteria:\n\n* Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff\n* Primary psychiatric disorder that would influence ability to participate\n* Receiving current treatment for epilepsy\n* Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded\n* History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)\n* Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)\n* Treatment for a communicable skin disorder currently or over the past 12 months\n* History of uncontrolled or labile hypertension\n* Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)\n* Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score \\< 85\n* History of clinically significant abnormalities on electrocardiogram (EKG)\n* Presence of chronic medical illness and/or severe ataxia\n* Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months\n* Alcohol or other substance use disorder\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03658668', 'briefTitle': 'Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Study of the Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '18-00534'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active tDCS+PA', 'interventionNames': ['Device: active tDCS', 'Other: Physical Activity (PA)']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tDCS+PA', 'interventionNames': ['Device: sham tDCS', 'Other: Physical Activity (PA)']}], 'interventions': [{'name': 'active tDCS', 'type': 'DEVICE', 'otherNames': ['Soterix 1x1 tDCS mini-CT'], 'description': 'tDCS is a therapeutic treatment that utilizes low amplitude direct currents (\\<4 mA) to induce changes in cortical excitability.', 'armGroupLabels': ['active tDCS+PA']}, {'name': 'sham tDCS', 'type': 'DEVICE', 'description': 'During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.', 'armGroupLabels': ['sham tDCS+PA']}, {'name': 'Physical Activity (PA)', 'type': 'OTHER', 'description': '20 minutes of cycling on an ergonomic cross-trainer', 'armGroupLabels': ['active tDCS+PA', 'sham tDCS+PA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Leigh Charvet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}