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

Primary Purpose

Cervical Dystonia,Primary

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Botulinum Toxin+SPRInt
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dystonia,Primary

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Fondazione Don GnocchiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Botulinum toxin+SPRInt protocol

Arm 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.

Outcomes

Primary Outcome Measures

Dystonia phenomenology improvement
a clinical assessment of dystonia will be conducted at each study visit using TWSTRS

Secondary Outcome Measures

quality of life
a clinical assessment of dystonia severity will be conducted at each study visit using quality of life scale (EQ5D5L)
brain plasticity
study of functional connectivity using functional magnetic resonance
depression
depression scale (BECK)
anxiety
anxiety scale (ZUNG)
structural grey matter plasticity
brain study of morphometry using functional magnetic resonance
structural white matter plasticity
tractography of brain areas using functional magnetic resonance
kinematic assessment of dystonia severity
visit with optoelectronic system

Full Information

First Posted
July 27, 2017
Last Updated
August 11, 2017
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT03247868
Brief Title
A Multimodal Approach to Cervical Dystonia Treatment With Association of Botulinum Toxin and Motor Learning Techniques
Acronym
SPRInt
Official Title
Multimodal Treatment of Cervical Dystonia With Botulinum Toxin Injections Associated With a Sensory-motor Perceptive Rehabilitation Integrated Approach (SPRInt) Based on Motor Learning Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2016 (undefined)
Primary Completion Date
March 28, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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) Severity Disability 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia,Primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin+SPRInt protocol
Arm Type
Experimental
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
Botulinum Toxin+SPRInt
Intervention Description
Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt)
Primary Outcome Measure Information:
Title
Dystonia phenomenology improvement
Description
a clinical assessment of dystonia will be conducted at each study visit using TWSTRS
Time Frame
every six weeks during six months time
Secondary Outcome Measure Information:
Title
quality of life
Description
a clinical assessment of dystonia severity will be conducted at each study visit using quality of life scale (EQ5D5L)
Time Frame
every six weeks during six months time
Title
brain plasticity
Description
study of functional connectivity using functional magnetic resonance
Time Frame
every six weeks during six months time
Title
depression
Description
depression scale (BECK)
Time Frame
every six weeks during six months time
Title
anxiety
Description
anxiety scale (ZUNG)
Time Frame
every six weeks during six months time
Title
structural grey matter plasticity
Description
brain study of morphometry using functional magnetic resonance
Time Frame
every six weeks during six months time
Title
structural white matter plasticity
Description
tractography of brain areas using functional magnetic resonance
Time Frame
every six weeks during six months time
Title
kinematic assessment of dystonia severity
Description
visit with optoelectronic system
Time Frame
every six weeks during six months time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Castagna, MD
Phone
+39 02 40308075
Email
acastagna@dongnocchi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Castagna, MD
Organizational Affiliation
IRCCS Fondazione Don Gnocchi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Fondazione Don Gnocchi
City
Milano
State/Province
MI
ZIP/Postal Code
20148
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Castagna, MD
Phone
+3902 40308075
Email
acastagna@dongnocchi.it

12. IPD Sharing Statement

Plan to Share IPD
No
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derived

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

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