Cervical Dystonia,Primary Clinical Trial
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
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.
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.
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