Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-07 @ 2:24 AM
Study NCT ID:
NCT02288533
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2014-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018458', 'term': 'Persistent Vegetative State'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coma Recovery Scale Revised (CRS-R)', 'timeFrame': 'Change measures (weeks: -2,0,1,2,4)', 'description': 'behavioural scale (visual, auditory, motor, verbal, communication, arousal)'}], 'secondaryOutcomes': [{'measure': 'single-pulse transcranial magnetic stimulation (TMS)', 'timeFrame': 'Change measures (weeks: -2,0,1,2,4)', 'description': 'cortical excitability measures'}, {'measure': 'functional near infrared spectroscopy (fNIRS)', 'timeFrame': 'Change measures (weeks: -2,0,1,2,4)', 'description': 'cerebral perfusion'}, {'measure': 'electroencephalography (EEG)', 'timeFrame': 'Change measures (weeks: -2,0,1,2,4)', 'description': 'To assess if, after tDCS administration, MCS patients could show: electroencephalographic pattern modifications'}, {'measure': 'Circulating Biomarkers', 'timeFrame': 'Change measures (weeks: -2,0,1,2,4)', 'description': 'blood biomarker levels modifications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Minimally Conscious State', 'tDCS'], 'conditions': ['Minimally Conscious State', 'TBI']}, 'descriptionModule': {'briefSummary': 'Chronic consciousness disorders have high level of impact on public health and its costs.', 'detailedDescription': "Consciousness disorders have high impact on society and national health system. One of these disorders is vegetative condition in which, as in coma, there isn't any self or environmental consciousness but there is alertness, whereas in minimal state of consciousness at least part of awareness is conserved.\n\nIn Emilia Romagna region about 80 people per million of inhabitants are hospitalized after cerebral damage, and after discharge about 1/5 of patients are stabilized in a consciousness disorder.\n\nThe diagnosis of these disorders is based on neurobehavioural tests, for example JFK Coma Recovery Scale Revised (CRS-R).\n\nIn these patients recovery of state of consciousness is one of the main challenges. There are very little evidences about treatment, it has been proposed the use of therapies that could modulate central nervous system activity, like specific drugs, neuroimaging and neuromodulation techniques such as transcranial magnetic stimulation and repetitive transcranial current stimulation.\n\nA non invasive neuromodulation technique is transcranial direct current stimulation (tDCS) which can modulate cortical excitability: cathodic current reduces excitability whereas anodic current increases it.\n\nIn conclusion, tDCS is an easy technique to use, it's not invasive and it's an efficient tool for the modulation of cortical excitability that demonstrated reliable results in healthy subjects.\n\nAs the tDCS can modulate cortical excitability it is likely that the combination of this stimulation tool with transcranial magnetic stimulation for the registration of cortical excitability could give important information about cerebral damage in patients with consciousness disorders and to test new treatments. It is also likely that the modification of cortical excitability could induce neurobehavioural changes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and females aged \\>18 years old and \\<70 years old\n* diagnosis of disorders of consciousness classified as MCS according to criteria of American Academy of Neurology1.\n* traumatic etiology (\\>12 months after the acute injury)\n\nExclusion Criteria:\n\n* contraindications to single pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants, history of seizures, metal in the head, implanted brain medical devices.\n* contraindications to tDCS such as metal in the head, implanted brain medical devices.'}, 'identificationModule': {'nctId': 'NCT02288533', 'briefTitle': 'Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Transcranial Direct Current Stimulation (tDCS) Effects in Patients With Chronic Consciousness Disorders', 'orgStudyIdInfo': {'id': 'Regionale WP2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'real-tDCS', 'description': 'Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).', 'interventionNames': ['Device: real-tDCS']}], 'interventions': [{'name': 'real-tDCS', 'type': 'DEVICE', 'description': 'Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).', 'armGroupLabels': ['real-tDCS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ferrara', 'state': 'Italy', 'country': 'Italy', 'facility': 'Ferrara University Hospital', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'overallOfficials': [{'name': 'Sofia Straudi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ferrara Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sofia Straudi, MD', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}