Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-02 @ 11:28 PM
Study NCT ID:
NCT03528018
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2018-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}, {'id': 'D001134', 'term': 'Arm Injuries'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-16', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Upper Extremity subscale of the Fugl-Meyer Assessment Scale from baseline to the end of the intervention and from the end of the intervention to one-month after the intervention', 'timeFrame': 'Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)', 'description': 'The Fugl-Meyer Assessment of Motor Recovery after Stroke evaluates and measures recovery in post-stroke hemiplegic patients in both clinical and research settings. Score range: 0-66'}], 'secondaryOutcomes': [{'measure': 'Change in the Time subscale of the Wolf Motor Function Test from baseline to the end of the intervention and from the end to one-month after the intervention', 'timeFrame': 'Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)', 'description': 'The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-1200'}, {'measure': 'Change in the Functional ability subscale of the Wolf Motor Function Test from baseline to the end of the intervention and from the end to one-month after the intervention.', 'timeFrame': 'Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)', 'description': 'The Wolf Motor Function Test is a quantitative measure of upper extremity motor ability through timed and functional tasks. Score range: 0-75'}, {'measure': 'Change in the Nottingham Sensory Assessment from baseline to the end of the intervention and from the end to one-month after the intervention.', 'timeFrame': 'Pre-intervention (within 5 days prior intervention), post-intervention (within 5 days after intervention), one-month follow-up (within 30 to 35 days after the intervention)', 'description': 'The Nottingham Sensory Assessment is a multi-modal sensory examination that includes tests of tactile sensation (Score range: 0-2) (light, touch, touch localization, temperature discrimination, pinprick sensation, bilateral simultaneous stimulation), kinesthesia (Score range:0-3), and stereognosis (Score range: 0-2)'}, {'measure': 'Intrinsic Motivation Inventory', 'timeFrame': 'Post-intervention (within 5 days after intervention)', 'description': 'The Intrinsic Motivation Inventory is a multidimensional questionnaire structured into various subscales. In this study, this questionnaire was used to assess participant interest/enjoyment, perceived competence, pressure/tension, and value/usefulness measures. Score range for each subscale: 1-7'}, {'measure': 'System Usability Scale', 'timeFrame': 'Post-intervention (within 5 days after intervention)', 'description': 'The System Usability Scale is a simple ten-item scale that serves as a global assessment of subjective usability. Score range: 0-100'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Rehabilitation', 'Physical therapy'], 'conditions': ['Stroke', 'Hemiparesis', 'Chronic Stroke', 'Upper Limb Injury']}, 'descriptionModule': {'briefSummary': 'Rehabilitation options for stroke survivors who present severe hemiparesis in chronic stages are limited and may end in compensation techniques that involve the use of the less affected arm to achieve some degree of functional independence. Transcranial direct current stimulation (tDCS) is a non-invasive technique that has been used after stroke to promote excitability of the surviving neural architecture in order to support functional recovery. Interestingly, cortical excitability has been reported to increase when tDCS is combined with virtual reality. This synergetic effect could explain the promising results achieved by preliminary experimental interventions that combined both approaches on upper limb rehabilitation after stroke. The objective of this study is to explore the use of these interventions in subjects with severe hemiparesis and to determine its efficacy in comparison to conventional physical therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronicity \\> six months\n* severe paresis of the upper limb defined by the Brunnstrom Approach as stages I or II and by the Upper Extremity subscale of the Fugl-Meyer Assessment as scores below 19\n* ability to maintain a sitting position for at least 60 minutes\n* fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23.\n\nExclusion Criteria:\n\n* pacemakers\n* brain implants or other metallic objects (valves, coils, etc.)\n* impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45\n* severe visual impairments\n* emotional or behavioral circumstances that impede adequate collaboration'}, 'identificationModule': {'nctId': 'NCT03528018', 'acronym': 'REACT01', 'briefTitle': 'Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Hospitales Nisa'}, 'officialTitle': 'Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality-based Paradigm for Upper Limb Rehabilitation in Individuals With Severe Hemiparesia. A Randomized Control Trial Survivor With Severe Hemiparesis', 'orgStudyIdInfo': {'id': 'NISA-PHYS-2016/1'}, 'secondaryIdInfos': [{'id': 'TIN2014-61975-EXP', 'type': 'OTHER_GRANT', 'domain': 'Ministerio de Economía y Competitividad of Spain'}, {'id': 'BES-2014-068218', 'type': 'OTHER_GRANT', 'domain': 'Ministerio de Economía y Competitividad of Spain'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Conventional physical therapy', 'interventionNames': ['Other: Physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Combined tDCS and VR-based intervention', 'interventionNames': ['Device: REACt system', 'Other: Physical therapy']}], 'interventions': [{'name': 'REACt system', 'type': 'DEVICE', 'description': 'The REACt system is a virtual reality-based paradigm for upper limb rehabilitation that allows for interaction of individuals with restricted movements from active responses triggered when they attempt to perform a movement. The experimental system also provides multisensory stimulation in the visual, auditory, and tactile channels, and transcranial direct current stimulation coherent to the observed movements', 'armGroupLabels': ['Experimental']}, {'name': 'Physical therapy', 'type': 'OTHER', 'description': 'Physical therapy included passive and active mobilization of the paretic upper limb. Passive range of motion exercises were provided in those segments where no active movement was detected to meticulously reproduce a range of articular movements and muscle and soft tissue elongation. In case of residual active movement capability, participants were encouraged to perform the movements with the assistance of the therapists', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46011', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Roberto Llorens, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat Politècnica de València'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitales Nisa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitat Politècnica de València', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}