Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-21 @ 5:56 AM
Study NCT ID:
NCT05842551
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prismatic Lenses and tDCS in Neglect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological outcome', 'timeFrame': 'Change from baseline OCS at 2 weeks', 'description': 'Oxford Cognitive Screening (OCS): is structured in 10 subtests: picture naming (0-4); semantics (0-3); orientation (0-4); visual field (0-4); sentence reading (0-15); number writing (0-3); calculation (0-4); broken hearts (0-50); praxis (0-12); recall and recognition (0-4); trails task (0-13)'}, {'measure': 'Neuropsychological outcome', 'timeFrame': 'Change form baseline the semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks', 'description': 'The semi structured scale for the functional evaluation of extrapersonal neglect (0-9); high score means a worse outcome'}, {'measure': 'Neuropsychological outcome', 'timeFrame': 'Change form baseline the semi structured scale for the functional evaluation of personal neglect at 2 weeks', 'description': 'The semi structured scale for the functional evaluation of personal neglect (0-9); high score means worse outcome'}, {'measure': 'Neuropsychological outcome', 'timeFrame': 'Change from baseline the Bergegò Scale at 2 weeks.', 'description': 'Bergegò Scale (0-30); high score means a better outcome'}, {'measure': 'Functional outcome', 'timeFrame': 'Change from baseline the Barthel Index at 2 weeks', 'description': 'Barthel Index (0-100); high score means a better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'neglect', 'tDCS', 'prismatic lenses'], 'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to to evaluate the effect and feasibility of a rehabilitation protocol with prismatic lenses associated with tDCS, compared to a prismatic lens rehabilitation protocol associated with sham stimulation, in reducing the signs of neglect in a group of patients with spatial heminegligence following ischemic stroke of the right hemisphere.\n\nThe secondary objective is to evaluate the impact of this rehabilitation protocol on functional outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* ischemic stroke\n* hospitalization within 90 days of the event\n\nExclusion Criteria:\n\n* heamorrhagic stroke\n* history of neurological disease\n* history of psychiatric disease\n* use of alchool and drugs'}, 'identificationModule': {'nctId': 'NCT05842551', 'briefTitle': 'Prismatic Lenses and tDCS in Neglect', 'organization': {'class': 'OTHER', 'fullName': 'Istituti Clinici Scientifici Maugeri SpA'}, 'officialTitle': 'The Effect of Prismatic Lenses in Association With tDCS in Patients With Neglect: a Pilot Study', 'orgStudyIdInfo': {'id': '1183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Patients will receive anodic tEs combined with prismatic lenses for two weeks', 'interventionNames': ['Combination Product: Prismatic adaptation and electric stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Patients will receive sham tEs combined with prismatic lenses for two weeks', 'interventionNames': ['Combination Product: Prismatic adaptation and electric stimulation']}], 'interventions': [{'name': 'Prismatic adaptation and electric stimulation', 'type': 'COMBINATION_PRODUCT', 'description': 'Combinatory effect of tEs and prismatic lenses in the experimental group and of sham stimulation and prismatic lenses in control group', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70025', 'city': 'Bari', 'state': 'Ba', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona Spaccavento', 'role': 'CONTACT'}], 'facility': 'Istituti Clinici Scientifici Maugeri', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'centralContacts': [{'name': 'Simona Spaccavento', 'role': 'CONTACT', 'email': 'simona.spaccavento@icsmaugeri.it', 'phone': '+393332783524'}], 'overallOfficials': [{'name': 'Simona Spaccavento', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituti Clinici Scientifici Maugeri'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituti Clinici Scientifici Maugeri SpA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda USL Toscana Sud Est', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Simona Spaccavento', 'investigatorAffiliation': 'Istituti Clinici Scientifici Maugeri SpA'}}}}