Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:00 AM
Study NCT ID:
NCT01371760
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2011-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical parameters in an integrated functional score', 'timeFrame': 'Baseline; 12 months', 'description': 'Five neurological parameters will be measured by the means of proper validated tools along 1 year of follow-up. The evaluation leads to a score, respectively expressed as improved, stable, fluctuant, worsened.'}, {'measure': 'MRI outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation.', 'timeFrame': 'Baseline; 12 months', 'description': 'Standard MRI parameters will be assessed by the means of a blinded centre of lecture. Outcome measurement will be performed at baseline, 6 months and at 1 year follow-up.'}], 'secondaryOutcomes': [{'measure': 'EDSS', 'timeFrame': 'Baseline; 12 months', 'description': 'EDSS will be assessed along 1 year follow-up.'}, {'measure': 'Chronic fatigue', 'timeFrame': 'Baseline; 12 months', 'description': 'This highly disabling symptom completely orphan of effective therapy will be measured by M-FIS (Modified-Fatigue Impact Scale).'}, {'measure': 'Cognitive function', 'timeFrame': 'Baseline; 12 months', 'description': 'Cognitive functions will be measured by the means of MoCA mental state questionnaire.'}, {'measure': 'Annualized relapse rate', 'timeFrame': 'Baseline; 12 months', 'description': 'In the sub population affected by the RR clinical form the number of relapse will be assessed.'}, {'measure': 'Patency rate', 'timeFrame': 'Baseline; 12 months', 'description': 'The rate of successful PTA will be assessed by the means of postoperative Doppler sonography.'}, {'measure': 'Emotional status', 'timeFrame': 'Baseline; 1 year', 'description': 'Anxiety and Depression Scale for use with multiple sclerosis patients will be administered.'}, {'measure': 'Memory and cognition', 'timeFrame': 'Baseline; 1 year', 'description': 'The assessment will be performed by the means of PASAT - Paced Auditory Serial Addition Test'}, {'measure': 'Overactive Bladder', 'timeFrame': 'Baseline; 1 year', 'description': 'Overactive Bladder symptom will be measured by the means of validated Overactive Bladder Questionnaire-b.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Chronic cerebrospinal venous insufficiency', 'Percutaneous Transluminal Angioplasty (PTA)', 'Internal jugular vein', 'Azygous vein'], 'conditions': ['Multiple Sclerosis', 'Venous Insufficiency']}, 'referencesModule': {'references': [{'pmid': '19958985', 'type': 'RESULT', 'citation': 'Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Gianesini S, Bartolomei I, Mascoli F, Salvi F. A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency. J Vasc Surg. 2009 Dec;50(6):1348-58.e1-3. doi: 10.1016/j.jvs.2009.07.096.'}, {'pmid': '31735108', 'type': 'DERIVED', 'citation': 'Zamboni P, Galeotti R, Salvi F, Giaquinta A, Setacci C, Alborino S, Guzzardi G, Sclafani SJ, Maietti E, Veroux P; Brave Dreams Research Group. Effects of Venous Angioplasty on Cerebral Lesions in Multiple Sclerosis: Expanded Analysis of the Brave Dreams Double-Blind, Sham-Controlled Randomized Trial. J Endovasc Ther. 2020 Feb;27(1):1526602819890110. doi: 10.1177/1526602819890110. Epub 2019 Nov 17.'}, {'pmid': '29150995', 'type': 'DERIVED', 'citation': "Zamboni P, Tesio L, Galimberti S, Massacesi L, Salvi F, D'Alessandro R, Cenni P, Galeotti R, Papini D, D'Amico R, Simi S, Valsecchi MG, Filippini G; Brave Dreams Research Group. Efficacy and Safety of Extracranial Vein Angioplasty in Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2018 Jan 1;75(1):35-43. doi: 10.1001/jamaneurol.2017.3825."}, {'pmid': '23034121', 'type': 'DERIVED', 'citation': "Zamboni P, Bertolotto A, Boldrini P, Cenni P, D'Alessandro R, D'Amico R, Del Sette M, Galeotti R, Galimberti S, Liberati A, Massacesi L, Papini D, Salvi F, Simi S, Stella A, Tesio L, Valsecchi MG, Filippini G; Chair of the Steering Committee. Efficacy and safety of venous angioplasty of the extracranial veins for multiple sclerosis. Brave dreams study (brain venous drainage exploited against multiple sclerosis): study protocol for a randomized controlled trial. Trials. 2012 Oct 3;13:183. doi: 10.1186/1745-6215-13-183."}], 'seeAlsoLinks': [{'url': 'http://www.ospfe.it', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To assess in a double blinded randomized control trial (RCT) study design safety and effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in multiple sclerosis (MS) associated to chronic cerebrospinal venous insufficiency (CCSVI).\n\nMean follow-up 1 year. 5-8 Italian centres 360 relapsing remitting (RR) MS patients will be randomized, with expanded disability disease scale (EDSS) ranging 2-5.5, age 18-65.', 'detailedDescription': 'Safety will be assessed by measuring serious and minor adverse effects related to treatment.\n\nEffectiveness will be assessed by measuring 2 primary endpoints:\n\n1. Clinical parameters will be expressed in an integrated functional measure leading to the score, respectively, of improved, stable, worsened. Functional assessment is performed by tools permitting a quantification and will be made by a team of independent assessors. Clinical instrumental evaluation will be performed at baseline, and subsequently on 3 months basis. The outcome parameters leading to the composite functional measure are instrumental parameters, less assessor dependent, singularly validated for measuring the disability in MS. They are the followings: A) Dynamic Balance Assessment: Balance Master Limits of Stability (LOS). In static platform, swinging to reach the set position of center of pressure. B) Walking Function: The subject walks spontaneously for 10 meters with chronometric measure of time counting the number of steps. The test calculates the walk ratio i.e. ratio between length and step frequency. C) Manual dexterity. Box \\& Block test, moving wooden cubes. D) Sphincter control: Post-voiding residual by ultrasounds. F) Visual acuity: Low-contrast visual acuity Sloan Letter Chart.\n2. Magnetic Resonance Imaging (MRI) outcome measures: T1Gad active lesion.T2 lesion volume MRI evaluation at baseline, 6, 12 months.\n\nSecondary endpoints are: EDSS, chronic fatigue, cognitive function, rate of restenosis, annualized relapse rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients affected by CCSVI associated with MS\n* relapsing-remitting and\\\\or secondary progressive\n* 18-65 years old\n* EDSS 2-5\n* disease duration \\< 10y\n* No relapse in the 30 days preceding the procedure\n* clinical stability in the last 6 months with disease mod. treatments\n* Patients under the best available therapy\n\nExclusion Criteria:\n\n* patients previously treated for CCSVI or inserted in other clinical trials in the last 3 months\n* under treatment with natalizumab\n* pregnant or refusing to adopt contraception\n* presence of significant comorbidities\n* alcool-drug abuse\n* thrombophilia\n* contraindication to MR'}, 'identificationModule': {'nctId': 'NCT01371760', 'acronym': 'BRAVE-DREAMS', 'briefTitle': 'BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)', 'organization': {'class': 'OTHER', 'fullName': 'S. Anna Hospital'}, 'officialTitle': "Randomized Multi-centered Study for Evaluating the Efficacy and Safety of Angioplastic Surgery of the Extracranial Veins in the Treatment of Multiple Sclerosis. Studio Randomizzato Multicentrico Per la Valutazione Dell'Efficacia e Sicurezza Dell'Intervento di Disostruzione Delle Vene Extracraniche Nel Trattamento Della Sclerosi Multipla", 'orgStudyIdInfo': {'id': 'S. Anna Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The patients will undergo PTA of the extracranial cerebral veins', 'interventionNames': ['Procedure: Venous PTA']}, {'type': 'SHAM_COMPARATOR', 'label': 'Controls', 'description': 'The patients will undergo sham procedure', 'interventionNames': ['Other: Catheter Venography']}], 'interventions': [{'name': 'Venous PTA', 'type': 'PROCEDURE', 'description': 'PTA of the internal jugular and/or azygous vein', 'armGroupLabels': ['Intervention']}, {'name': 'Catheter Venography', 'type': 'OTHER', 'description': 'The patients will undergo catheter venography but not PTA', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44100', 'city': 'Ferrara', 'state': 'Fe', 'country': 'Italy', 'facility': 'S. Anna Hospital', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '44100', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'S. Anna Hospital, University of Ferrara, Ferrara, Italy', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'overallOfficials': [{'name': 'Paolo Zamboni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S. Anna Hospital, University of Ferrara, Ferrara, Italy'}, {'name': 'Graziella Filippini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Neurologico Besta, Milano, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data analysis on behalf of the independent Biostatistic Center will be completed within May 2016'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S. Anna Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regione Emilia-Romagna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Paolo Zamboni', 'investigatorAffiliation': 'S. Anna Hospital'}}}}