Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-27 @ 10:31 PM
Study NCT ID:
NCT01636661
Status:
COMPLETED
Last Update Posted:
2015-11-09
First Post:
2012-06-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}], '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'}]}, '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': 'brown029@umn.edu', 'phone': '612.626.6415', 'title': 'Dr. Bernadette Gillick', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Receiving active tDCS\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham tDCS', 'description': 'tDCS equipment set to placebo setting.\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Itching', 'notes': 'Reports of tingling under the electrodes. Assessed verbally by participant feedback at scheduled intervals: pre/post and follow-up sessions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events/Safety Assessment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Receiving active tDCS\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'tDCS equipment set to placebo setting.\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}], 'classes': [{'title': 'Any Change in Vital Signs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decline in Physician Evaluation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reported Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Posttest, Follow-Up Session at One-Week', 'description': 'Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:\n\n1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.\n2. Physician Evaluation- Child identified as declining in function from pretest to posttest.\n3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.\n\nDetailed adverse events are reported in the adverse events module.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Pilot study therefore no sample size analysis. Completed per protocol.'}, {'type': 'SECONDARY', 'title': 'Hand Function Decline as Measured by Number of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Receiving active tDCS\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}, {'id': 'OG001', 'title': 'Sham tDCS', 'description': 'tDCS equipment set to placebo setting.\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Posttest, Follow-Up Session at One-Week', 'description': 'Measured by the Box and Blocks Test and Grip Strength', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Receiving active tDCS\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}, {'id': 'FG001', 'title': 'Sham tDCS', 'description': 'tDCS equipment set to placebo setting.\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'If a child did not exhibit a motor evoked potential from the ipsilesional cortex, they were excluded from the trial after enrollment but before assignment to a group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Transcranial Direct Current Stimulation', 'description': 'Receiving active tDCS\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}, {'id': 'BG001', 'title': 'Sham tDCS', 'description': 'tDCS equipment set to placebo setting.\n\ntDCS: transcranial direct current stimulation- non-invasive brain stimulation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '16.9', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '14.7', 'spread': '3.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Pilot study estimating a sample of children with hemiparesis. No formal sample size nor power analysis was performed.'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2012-06-11', 'resultsFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-22', 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events/Safety Assessment.', 'timeFrame': 'Baseline, Posttest, Follow-Up Session at One-Week', 'description': 'Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:\n\n1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.\n2. Physician Evaluation- Child identified as declining in function from pretest to posttest.\n3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.\n\nDetailed adverse events are reported in the adverse events module.'}], 'secondaryOutcomes': [{'measure': 'Hand Function Decline as Measured by Number of Participants', 'timeFrame': 'Baseline, Posttest, Follow-Up Session at One-Week', 'description': 'Measured by the Box and Blocks Test and Grip Strength'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemiparesis']}, 'referencesModule': {'references': [{'pmid': '25413621', 'type': 'RESULT', 'citation': 'Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.\n\nThe research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:\n\n1. tDCS will not produce a major adverse event, including seizure activity.\n2. No change in paretic or nonparetic hand function or cognitive status will occur.', 'detailedDescription': 'Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.\n2. Hemispheric Stroke or Periventricular Leukomalacia\n3. Ages 8-17 years old\n4. ≥ 10 degrees of active motion at the metacarpophalangeal joint\n5. Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence\n6. No evidence of seizure activity within the last 2 years.\n7. Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.\n\nExclusion Criteria:\n\n1. Metabolic Disorders\n2. Neoplasm\n3. Epilepsy\n4. Disorders of Cellular Migration and Proliferation\n5. Acquired Traumatic Brain Injury\n6. Expressive Aphasia\n7. Pregnancy\n8. Indwelling metal or incompatible medical devices\n9. Evidence of skin disease or skin abnormalities\n10. Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS'}, 'identificationModule': {'nctId': 'NCT01636661', 'acronym': 'tDCS', 'briefTitle': 'Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis', 'orgStudyIdInfo': {'id': '1205M13901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcranial Direct Current Stimulation', 'description': 'Receiving active tDCS', 'interventionNames': ['Device: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': 'tDCS equipment set to placebo setting.', 'interventionNames': ['Device: tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'DEVICE', 'otherNames': ['transcranial direct current stimulation'], 'description': 'transcranial direct current stimulation- non-invasive brain stimulation', 'armGroupLabels': ['Sham tDCS', 'Transcranial Direct Current Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Bernadette Gillick, PhD, MS, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minnesota Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}