Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT01749735
Status:
TERMINATED
Last Update Posted:
2017-05-04
First Post:
2011-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Direct Current Stimulation (tDCS) and Motor Training for Traumatic Brain Injury (TBI) Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': 'pbonato@partners.org', 'phone': '617-952-6319', 'title': 'Dr. Paolo Bonato', 'organization': 'Spaulding Rehabilitation Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patient 1 did not finish study (stopped in follow up week 2). Patient 2 missed 2 training sessions. Both patients received the intervention (tDCS group) according to the confidential patient log. There was no control group available for comparison.'}}, 'adverseEventsModule': {'timeFrame': 'No adverse events were observed', 'eventGroups': [{'id': 'EG000', 'title': 'Armeo Training With Continuous tDCS', 'description': 'Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Armeo Training With Sham tDCS', 'description': 'Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Arm Pain', 'notes': "One subject experienced arm pain, an expected adverse event related to the performance of rehabilitation exercises. The subject chose not to complete the final evaluation visit. The subject's physician prescribed Advil and the problem was resolved.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Jebsen-Taylor Hand Function Test Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Armeo Training With Continuous tDCS', 'description': 'Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}, {'id': 'OG001', 'title': 'Armeo Training With Sham tDCS', 'description': 'Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}], 'classes': [{'title': 'Day 5', 'categories': [{'measurements': [{'value': '-71.9', 'spread': '67.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '-79.0', 'spread': '66.6', 'groupId': 'OG000'}]}]}, {'title': '1 week post', 'categories': [{'measurements': [{'value': '-20.1', 'spread': '151.2', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post', 'categories': [{'measurements': [{'value': '-17.4', 'spread': 'NA', 'comment': 'No follow up in one subject', 'groupId': 'OG000'}]}]}, {'title': '4 weeks post', 'categories': [{'measurements': [{'value': '-26.9', 'spread': 'NA', 'comment': 'No follow up in one subject', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post', 'description': 'The Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Box and Block Test Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Armeo Training With Continuous tDCS', 'description': 'Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}, {'id': 'OG001', 'title': 'Armeo Training With Sham tDCS', 'description': 'Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}], 'classes': [{'title': 'Day 5', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': '1 week post', 'categories': [{'measurements': [{'value': '3', 'spread': '4.2', 'groupId': 'OG000'}]}]}, {'title': '2 weeks post', 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': '4 weeks post', 'categories': [{'measurements': [{'value': '6', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post', 'description': 'The Box and Block Test is a functional test. Subjects are instructed to move small blocks from one box to a second box. The test measures the number of blocks that subjects can move during a period of 60 sec. The measurement unit for this task is the "number of blocks". Subjects with no motor impairments would typically move about 60 to 80 blocks in a period of 60 sec.', 'unitOfMeasure': 'number of blocks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Armeo Training With Continuous tDCS', 'description': 'Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}, {'id': 'FG001', 'title': 'Armeo Training With Sham tDCS', 'description': 'Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Recruitment target (30) was not reached for this study. Inclusion/exclusion criteria were very restrictive hence making it difficult to recruit subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Armeo Training With Continuous tDCS', 'description': 'Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}, {'id': 'BG001', 'title': 'Armeo Training With Sham tDCS', 'description': 'Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.\n\nArmeo training: Upper extremity training with the use of a weight support device and virtual reality.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '8', 'groupId': 'BG000'}, {'value': '52.5', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'The study was terminated because of lack of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-30', 'studyFirstSubmitDate': '2011-12-06', 'resultsFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2012-12-12', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-17', 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Jebsen-Taylor Hand Function Test Score From Baseline', 'timeFrame': 'Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post', 'description': 'The Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.'}, {'measure': 'Change in Box and Block Test Score From Baseline', 'timeFrame': 'Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post', 'description': 'The Box and Block Test is a functional test. Subjects are instructed to move small blocks from one box to a second box. The test measures the number of blocks that subjects can move during a period of 60 sec. The measurement unit for this task is the "number of blocks". Subjects with no motor impairments would typically move about 60 to 80 blocks in a period of 60 sec.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://srh-mal.net/case/the-effect-of-transcranial-direct-current-stimulation-combined-with-functional-task-training-on-motor-recovery-in-traumatic-brain-injury-survivors/', 'label': 'short description of the study'}, {'url': 'http://www.neuromodulationlab.org/index.php?option=com_content&view=article&id=22&Itemid=67', 'label': 'short description of the study'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effect of transcranial direct current stimulation and functional upper extremity task training to functional upper extremity task training alone. The functional upper extremity task training uses the Armeo Spring robotic arm to support the limb while playing functional task games on a computer.\n\nSpecific Aims:\n\n1. To demonstrate that tDCS combined with upper extremity functional task training in a virtual environment is more effective than functional task training in a virtual environment with sham tDCS.\n2. To compare cortico-excitatory changes following training with tDCS vs. sham stimulation, using paired- and single-pulse transcranial magnetic stimulation as a tool to measure cortical excitability.', 'detailedDescription': 'This is a randomized, double-blinded, sham-controlled study comparing sham and continuous tDCS combined with repetitive upper extremity functional task training in a virtual environment. Subjects will be randomized to 1 of 2 groups: Armeo training with continuous tDCS, or sham tDCS through a randomization stratification approach. Subjects will be grouped into strata defined by the degree of weakness, and then randomized separately within each stratum according to a block randomization of 6 to receive Armeo training-continuous tDCS, or Armeo training-sham stimulation. Each subject will receive 10 training sessions over 2 weeks. Training sessions will last for 40 minutes and will focus on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand. We will use a variety of virtual tasks (computer games) in the training. Examples of the virtual tasks include 1) picking up objects from shelves placed against different walls of a room and placing them in a bin in the center foreground of the screen, 2) picking up eggs from a basket and cracking them over a frying pan, 3) picking up objects at a virtual supermarket and placing them in the shopping cart, 4) cleaning a stove top. In between training sessions, subjects will be encouraged to use the affected arm in daily activities. This will be assessed with the Motor Activity Log.\n\ntDCS will be delivered by positioning the anode over the primary motor cortex (M1) of the affected hemisphere, while the cathode will be placed over the unaffected M1 area. The electrode localization method will be according to the International 10-20 Electrode Placement System for placement of EEG electrodes. This method has been validated with a frameless stereotactic system. Direct current will be transferred by a saline-soaked pair of surface sponge electrode (35cm2) and delivered by a battery-driven, constant current stimulator with a maximum output of 10mA. An intensity of 1mA will be used in this study (current density of 0.04 μA/cm2). Continuous stimulation will be delivered at an intensity of 1mA while the subject undergoes the 40-minute Armeo motor training sessions. For sham stimulation, the same parameters will be employed. However, the current will be applied for 30 seconds only. Current intensity will be gradually increased and decreased to diminish its perception.\n\nOutcome measures will be performed prior to treatment initiation, at day 5, 10, and at follow-up week 1, 2 and 4 after the end of treatment. A rater blinded to the treatment will assess the effects of the intervention using the Jebsen-Taylor Hand Function Test and Box and Block Test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years\n* First-time moderate to severe TBI\n* Arm weakness\n\nExclusion Criteria:\n\n* History of seizures\n* Major depression\n* Agitated Behavior Scale \\>21\n* Cognitive Impairment that interferes with understanding instructions\n* Pregnancy\n* Implants (e.g. metal plates, shunts, pacemaker)\n* Participation in other upper extremity rehab or TBI study'}, 'identificationModule': {'nctId': 'NCT01749735', 'briefTitle': 'Transcranial Direct Current Stimulation (tDCS) and Motor Training for Traumatic Brain Injury (TBI) Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Traumatic Brain Injury Survivors', 'orgStudyIdInfo': {'id': '2009-P-000700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Armeo training with continuous tDCS', 'description': 'Subjects will receive 10 sessions of transcranial Direct Current Stimulation (tDCS)/Armeo training over 2 weeks. Training sessions will last for 40 minutes and will focus on repetitive tasks using the Armeo device that. To deliver the stimulation, the anode will be placed over the primary motor cortex (M1) of the affected hemisphere, while the cathode will be placed over the unaffected M1 area. Direct current will be transferred by a saline-soaked pair of surface sponge electrode (35cm2). Continuous stimulation will be delivered at an intensity of 1mA while the subject undergoes the 40-minute Armeo motor training sessions.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation', 'Device: Armeo training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Armeo training with sham tDCS', 'description': 'Subjects will receive the same number of 40-minute training sessions (i.e. 10 sessions) as the subjects in the experimental group. Training will take place over a period of two weeks as per the experimental group. Also, electrodes will be positioned on the scalp as per the experimental group. However, for sham transcranial Direct Current Stimulation (tDCS), the current will be delivered for only 30 seconds. The current intensity will be gradually increased and decreased to diminish its perception.', 'interventionNames': ['Device: Sham Transcranial Direct Current Stimulation', 'Device: Armeo training']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['Device name: Phoresor II Auto', 'Produced by: Iomed'], 'description': 'Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.', 'armGroupLabels': ['Armeo training with continuous tDCS']}, {'name': 'Sham Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['Device name: Phoresor II Auto', 'Produced by: Iomed'], 'description': 'Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.', 'armGroupLabels': ['Armeo training with sham tDCS']}, {'name': 'Armeo training', 'type': 'DEVICE', 'otherNames': ['Device: Armeo', 'Produced by: Hocoma'], 'description': 'Upper extremity training with the use of a weight support device and virtual reality.', 'armGroupLabels': ['Armeo training with continuous tDCS', 'Armeo training with sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Paolo Bonato, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Motion Analysis Lab', 'investigatorFullName': 'Paolo Bonato', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}