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

August 11, 2017 updated by: Fondazione Don Carlo Gnocchi Onlus

Multimodal Treatment of Cervical Dystonia With Botulinum Toxin Injections Associated With a Sensory-motor Perceptive Rehabilitation Integrated Approach (SPRInt) Based on Motor Learning Techniques

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20148
        • Recruiting
        • IRCCS Fondazione Don Gnocchi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Combination product: Botulinum Toxin+SPRInt
Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every six weeks during six months time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
every six weeks during six months time
brain plasticity
Time Frame: every six weeks during six months time
study of functional connectivity using functional magnetic resonance
every six weeks during six months time
depression
Time Frame: every six weeks during six months time
depression scale (BECK)
every six weeks during six months time
anxiety
Time Frame: every six weeks during six months time
anxiety scale (ZUNG)
every six weeks during six months time
structural grey matter plasticity
Time Frame: every six weeks during six months time
brain study of morphometry using functional magnetic resonance
every six weeks during six months time
structural white matter plasticity
Time Frame: every six weeks during six months time
tractography of brain areas using functional magnetic resonance
every six weeks during six months time
kinematic assessment of dystonia severity
Time Frame: every six weeks during six months time
visit with optoelectronic system
every six weeks during six months time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Anna Castagna, MD, IRCCS Fondazione Don Gnocchi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 16, 2016

Primary Completion (ANTICIPATED)

March 28, 2018

Study Completion (ANTICIPATED)

June 30, 2018

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (ACTUAL)

August 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPRIntFdG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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