Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT03247868
Status:
UNKNOWN
Last Update Posted:
2017-08-14
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multimodal Approach to Cervical Dystonia Treatment With Association of Botulinum Toxin and Motor Learning Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566572', 'term': 'Cervical Dystonia, Primary'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03-16'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dystonia phenomenology improvement', 'timeFrame': 'every six weeks during six months time', 'description': 'a clinical assessment of dystonia will be conducted at each study visit using TWSTRS'}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': 'every six weeks during six months time', 'description': 'a clinical assessment of dystonia severity will be conducted at each study visit using quality of life scale (EQ5D5L)'}, {'measure': 'brain plasticity', 'timeFrame': 'every six weeks during six months time', 'description': 'study of functional connectivity using functional magnetic resonance'}, {'measure': 'depression', 'timeFrame': 'every six weeks during six months time', 'description': 'depression scale (BECK)'}, {'measure': 'anxiety', 'timeFrame': 'every six weeks during six months time', 'description': 'anxiety scale (ZUNG)'}, {'measure': 'structural grey matter plasticity', 'timeFrame': 'every six weeks during six months time', 'description': 'brain study of morphometry using functional magnetic resonance'}, {'measure': 'structural white matter plasticity', 'timeFrame': 'every six weeks during six months time', 'description': 'tractography of brain areas using functional magnetic resonance'}, {'measure': 'kinematic assessment of dystonia severity', 'timeFrame': 'every six weeks during six months time', 'description': 'visit with optoelectronic system'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Dystonia,Primary']}, 'referencesModule': {'references': [{'pmid': '23649720', 'type': 'BACKGROUND', 'citation': 'Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6.'}, {'pmid': '19043661', 'type': 'BACKGROUND', 'citation': 'Boccagni C, Carpaneto J, Micera S, Bagnato S, Galardi G. Motion analysis in cervical dystonia. Neurol Sci. 2008 Dec;29(6):375-81. doi: 10.1007/s10072-008-1033-z. Epub 2008 Nov 29.'}, {'pmid': '25046267', 'type': 'BACKGROUND', 'citation': 'Walter U, Dressler D. Ultrasound-guided botulinum toxin injections in neurology: technique, indications and future perspectives. Expert Rev Neurother. 2014 Aug;14(8):923-36. doi: 10.1586/14737175.2014.936387. Epub 2014 Jul 21.'}, {'pmid': '24333801', 'type': 'BACKGROUND', 'citation': 'Prudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11.'}, {'pmid': '25447226', 'type': 'BACKGROUND', 'citation': 'Delnooz CC, Pasman JW, van de Warrenburg BP. Dynamic cortical gray matter volume changes after botulinum toxin in cervical dystonia. Neurobiol Dis. 2015 Jan;73:327-33. doi: 10.1016/j.nbd.2014.10.013. Epub 2014 Oct 28.'}, {'pmid': '23650536', 'type': 'BACKGROUND', 'citation': 'Delnooz CC, Pasman JW, Beckmann CF, van de Warrenburg BP. Task-free functional MRI in cervical dystonia reveals multi-network changes that partially normalize with botulinum toxin. PLoS One. 2013 May 1;8(5):e62877. doi: 10.1371/journal.pone.0062877. Print 2013.'}, {'pmid': '24413637', 'type': 'BACKGROUND', 'citation': 'De Pauw J, Van der Velden K, Meirte J, Van Daele U, Truijen S, Cras P, Mercelis R, De Hertogh W. The effectiveness of physiotherapy for cervical dystonia: a systematic literature review. J Neurol. 2014 Oct;261(10):1857-65. doi: 10.1007/s00415-013-7220-8. Epub 2014 Jan 12.'}, {'pmid': '23855591', 'type': 'BACKGROUND', 'citation': 'van den Dool J, Visser B, Koelman JH, Engelbert RH, Tijssen MA. Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial. BMC Neurol. 2013 Jul 15;13:85. doi: 10.1186/1471-2377-13-85.'}, {'pmid': '27164716', 'type': 'BACKGROUND', 'citation': 'Simpson DM, Hallett M, Ashman EJ, Comella CL, Green MW, Gronseth GS, Armstrong MJ, Gloss D, Potrebic S, Jankovic J, Karp BP, Naumann M, So YT, Yablon SA. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache [RETIRED]: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26. doi: 10.1212/WNL.0000000000002560. Epub 2016 Apr 18.'}, {'pmid': '15027056', 'type': 'BACKGROUND', 'citation': 'Curra A, Trompetto C, Abbruzzese G, Berardelli A. Central effects of botulinum toxin type A: evidence and supposition. Mov Disord. 2004 Mar;19 Suppl 8:S60-4. doi: 10.1002/mds.20011.'}, {'pmid': '23312633', 'type': 'BACKGROUND', 'citation': 'Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3.'}, {'pmid': '31478151', 'type': 'DERIVED', 'citation': 'Castagna A, Caronni A, Crippa A, Sciume L, Giacobbi G, Corrini C, Montesano A, Ramella M. Sensorimotor Perceptive Rehabilitation Integrated (SPRInt) program: exercises with augmented movement feedback associated to botulinum neurotoxin in idiopathic cervical dystonia-an observational study. Neurol Sci. 2020 Jan;41(1):131-138. doi: 10.1007/s10072-019-04061-5. Epub 2019 Sep 2.'}]}, 'descriptionModule': {'briefSummary': 'the aim of this study protocol is to describe, using a longitudinal study, a multimodal approach of treatment of cervical dystonia with botulinum toxin (BoNTA) and a new rehabilitation protocol named SPRInt (Sensory-motor perceptive rehabilitation integrated) approach based on motor learning techniques and spatial rehabilitation.', 'detailedDescription': 'Longitudinal study utilizing a multimodal treatment protocol developing in six months time:\n\nPhase 1 : BoNTA injections localized in dystonic cervical muscles with EMG/US guides performed after polygraphy and kinematic analysis of cervical region Times: T0: pre treatment; T1: 6 weeks after T0 considered BoNTA pharmacological peak effect; T2: 12 weeks after T0 considered from guidelines and pharmaceutical data sheet the lowest BoNTA effect.\n\nPhase 2: BoNTA performed in the same way of Phase 1 associated to SPRInt protocol Times: T2: before combination of BoNTA and rehabilitation treatment (18 sessions of 45 minutes three times a week); T3: 6 weeks after T2 considered BoNTA pharmacological peak effect and the end of SPRInt protocol; T4: 12 weeks after T2 considered from guidelines and pharmaceutical data sheet the lowest BoNTA effect and follow up of SPRInt-consolidation.\n\nThe SPRInt approach aims are to improve body perception, posture and movement quality and to restore body axis by using specific sensory feedbacks, both intrinsic (IFB) and extrinsic (EFB), and motor exercises (ME) with specific rhythmic temporal structure.The ME can be focused on different body parts (eyes, head, neck, trunk, arm) and involve different spatial planes (frontal, sagittal, horizontal, multiplanar).\n\nThe exercises can be performed with eyes closed and with an external passive motor leading in order to improve proprioception and facilitate sensory integration by excluding visual or verbal information that can be misleading for the patient. The ability to perceive and integrate intrinsic feedback is the fundamental element to create mental image that define body scheme and motor behaviour.\n\nThe extrinsic feedback can be continuous or discontinuous (on-off timing) and gives the patient information about the performance or result by positive or negative reinforcement; this process can be important to motivate and empower the patient in reaching new skills.\n\nThe final goal for the patient is to reinforce and retain the informations collected with working memory and then stored with the consolidation process which ends in learning new skills (ie rescue postural axis) and improving motor tasks (ie move the head in the opposite position).\n\nAt each time point these test are performed:\n\n* CLINICAL SCALES i. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)\n\n 1. Severity\n 2. Disability\n 3. Pain ii. Quality of life iii. Depression Beck Scale iv. Zung Self Rating Anxiety Scale v. Rey Test to test visuo spatial abilities\n* MOVEMENT ANALYSIS and KINEMATIC AND EMG MAPPING of cervical region ( head and neck)\n* FUNCTIONAL MAGNETIC RESONANCE BRAIN STUDY to perform brain measurements of functional connectivity (resting state-Default Mode Network), morphometry (volume, area, cortical thickness, cortical curvature, node degree) and tractography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 18 yo\n* diagnosis of idiopathic cervical dystonia\n* disease duration more than 6 months\n\nExclusion Criteria:\n\n* diagnosis of secondary dystonia on previously performed neuroimaging data (ie structural lesion of cervical spine, vascular or traumatic brain injuries)\n* history of neuroleptic drug treatment (antidopaminergic drugs)\n* associated neurological illness\n* botulinum toxin treatment in the 3 previous months before recruitment\n* head tremor without dystonic posturing'}, 'identificationModule': {'nctId': 'NCT03247868', 'acronym': 'SPRInt', 'briefTitle': 'A Multimodal Approach to Cervical Dystonia Treatment With Association of Botulinum Toxin and Motor Learning Techniques', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Multimodal Treatment of Cervical Dystonia With Botulinum Toxin Injections Associated With a Sensory-motor Perceptive Rehabilitation Integrated Approach (SPRInt) Based on Motor Learning Techniques', 'orgStudyIdInfo': {'id': 'SPRIntFdG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin+SPRInt protocol', 'description': 'patients affected by cervical dystonia receive botulinum toxin treatment (EMG-US guided injections in dystonic muscles) for two times at T0 and T2; after T2 patients are treated also with SPRInt rehabilitation protocol based on motor learning techniques.', 'interventionNames': ['Combination Product: Botulinum Toxin+SPRInt']}], 'interventions': [{'name': 'Botulinum Toxin+SPRInt', 'type': 'COMBINATION_PRODUCT', 'description': 'Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt)', 'armGroupLabels': ['Botulinum toxin+SPRInt protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20148', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Castagna, MD', 'role': 'CONTACT', 'email': 'acastagna@dongnocchi.it', 'phone': '+3902 40308075'}], 'facility': 'IRCCS Fondazione Don Gnocchi', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Anna Castagna, MD', 'role': 'CONTACT', 'email': 'acastagna@dongnocchi.it', 'phone': '+39 02 40308075'}], 'overallOfficials': [{'name': 'Anna Castagna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Fondazione Don Gnocchi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}