Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06823102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2025-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Connectivity Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate effects of tDCS in short-term follow-ups in terms of EEG Coherence', 'timeFrame': 'from month 8 to month 12', 'description': 'Analysis of Magnitude Squared Coherence to evaluate short-term tDCS effects'}, {'measure': 'Evaluate persistent effect of tDCS in long-term follow-ups of EEG Coherence', 'timeFrame': 'From month 15 to the end of project', 'description': 'Analysis of Magnitude Squared Coherence evaluate long-term tDCS effects'}, {'measure': 'Evaluate effects of tDCS in short-term follow-ups in terms of EEG Connectivity', 'timeFrame': 'from month 8 to month 12', 'description': 'Analysis of EEG Connectivity to evaluate short-term tDCS effects'}, {'measure': 'Evaluate persistent effect of tDCS in long-term follow-ups of EEG Connectivity', 'timeFrame': 'From month 15 to the end of project', 'description': 'Analysis of EEG Connectivity to evaluate long-term tDCS effects'}, {'measure': "Predict patients' outcome", 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Use of AI to predict the outcome of the patient'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non Invasive Brain Stimulation', 'Inflammation'], 'conditions': ['Neural Injury']}, 'descriptionModule': {'briefSummary': 'Stroke remains the leading cause of permanent disability. The neuromodulation technique of transcranial Direct Current Stimulation (tDCS) has the potential to serve as an adjuvant therapy to enhance neuronal connectivity following stroke. By combining electroencephalography (EEG) and tDCS, this study aims to investigate changes in network connectivity and cerebral plasticity, which are key factors in functional recovery after stroke.\n\nThe objectives are to: 1) analyze how tDCS modulates neuronal activity, 2) evaluate persistent effects in follow-up assessments, and 3) predict patient outcomes. Studies on human subjects will be complemented by research in a mouse model of stroke to: 1) identify the molecular mechanisms underlying tDCS effects on functional recovery, 2) establish correlations among functional, molecular, and connectivity indices, and 3) assess the efficacy of biomimetic nanoparticles in targeting injured brain tissue to reduce inflammation, enhance neuronal plasticity, and support functional recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18-90\n\n* First ischemic stroke occurring 3-30 days after onset\n* Residual upper limb function\n* Ability to provide informed consent and understand instructions\n\nExclusion Criteria:\n\n* Severe spasticity (Ashworth \\>2)\n* Presence of additional neurological diseases\n* Significant comorbidities\n* History of intracerebral hemorrhage\n* Severe neglect\n* Contraindications to tDCS'}, 'identificationModule': {'nctId': 'NCT06823102', 'acronym': 'Neurehab', 'briefTitle': 'Brain Connectivity Analysis', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele Roma'}, 'officialTitle': 'Brain Connectivity Analysis to Predict Post Stroke Outcomes Following Traditional and Enhanced Neurorehabilitation by Transcranial Direct Current Stimulation and Anti-inflammatory Biomimetic Nanoparticles', 'orgStudyIdInfo': {'id': 'RP 22/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS+standard rehabilitation', 'interventionNames': ['Other: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'tDCS sham+standard rehabilitation', 'interventionNames': ['Other: tDCS']}, {'type': 'NO_INTERVENTION', 'label': 'standard rehabilitation'}], 'interventions': [{'name': 'tDCS', 'type': 'OTHER', 'description': 'Transcranial direct current stimulation', 'armGroupLabels': ['tDCS sham+standard rehabilitation', 'tDCS+standard rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00163', 'city': 'Rome', 'state': 'Rome', 'country': 'Italy', 'facility': 'Casa di cura San Raffaele Pisana', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele Roma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}