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A Multimodal Approach to Cervical Dystonia Treatment With Association of Botulinum Toxin and Motor Learning Techniques (SPRInt)

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ClinicalTrials.gov Identifier: NCT03247868
Recruitment Status : Unknown
Verified July 2017 by Fondazione Don Carlo Gnocchi Onlus.
Recruitment status was:  Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus

Tracking Information
First Submitted Date  ICMJE July 27, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date August 14, 2017
Study Start Date  ICMJE March 16, 2016
Estimated Primary Completion Date March 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
Dystonia phenomenology improvement [ Time Frame: every six weeks during six months time ]
a clinical assessment of dystonia will be conducted at each study visit using TWSTRS
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2017)
  • quality of life [ Time Frame: every six weeks during six months time ]
    a clinical assessment of dystonia severity will be conducted at each study visit using quality of life scale (EQ5D5L)
  • brain plasticity [ Time Frame: every six weeks during six months time ]
    study of functional connectivity using functional magnetic resonance
  • depression [ Time Frame: every six weeks during six months time ]
    depression scale (BECK)
  • anxiety [ Time Frame: every six weeks during six months time ]
    anxiety scale (ZUNG)
  • structural grey matter plasticity [ Time Frame: every six weeks during six months time ]
    brain study of morphometry using functional magnetic resonance
  • structural white matter plasticity [ Time Frame: every six weeks during six months time ]
    tractography of brain areas using functional magnetic resonance
  • kinematic assessment of dystonia severity [ Time Frame: every six weeks during six months time ]
    visit with optoelectronic system
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multimodal Approach to Cervical Dystonia Treatment With Association of Botulinum Toxin and Motor Learning Techniques
Official Title  ICMJE Multimodal Treatment of Cervical Dystonia With Botulinum Toxin Injections Associated With a Sensory-motor Perceptive Rehabilitation Integrated Approach (SPRInt) Based on Motor Learning Techniques
Brief Summary 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.
Detailed Description

Longitudinal study utilizing a multimodal treatment protocol developing in six months time:

Phase 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.

Phase 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.

The 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).

The 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.

The 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.

The 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).

At each time point these test are performed:

  • CLINICAL SCALES i. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

    1. Severity
    2. Disability
    3. Pain ii. Quality of life iii. Depression Beck Scale iv. Zung Self Rating Anxiety Scale v. Rey Test to test visuo spatial abilities
  • MOVEMENT ANALYSIS and KINEMATIC AND EMG MAPPING of cervical region ( head and neck)
  • 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Dystonia,Primary
Intervention  ICMJE Combination Product: Botulinum Toxin+SPRInt
Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt)
Study Arms  ICMJE Experimental: Botulinum toxin+SPRInt protocol
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.
Intervention: Combination Product: Botulinum Toxin+SPRInt
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2018
Estimated Primary Completion Date March 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • more than 18 yo
  • diagnosis of idiopathic cervical dystonia
  • disease duration more than 6 months

Exclusion Criteria:

  • diagnosis of secondary dystonia on previously performed neuroimaging data (ie structural lesion of cervical spine, vascular or traumatic brain injuries)
  • history of neuroleptic drug treatment (antidopaminergic drugs)
  • associated neurological illness
  • botulinum toxin treatment in the 3 previous months before recruitment
  • head tremor without dystonic posturing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03247868
Other Study ID Numbers  ICMJE SPRIntFdG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fondazione Don Carlo Gnocchi Onlus
Study Sponsor  ICMJE Fondazione Don Carlo Gnocchi Onlus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna Castagna, MD IRCCS Fondazione Don Gnocchi
PRS Account Fondazione Don Carlo Gnocchi Onlus
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP