An interventional study of Botulinum Toxin+SPRInt in Cervical Dystonia,Primary, sponsored by Fondazione Don Carlo Gnocchi Onlus. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-14.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
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)
319 studies on the registry are indexed under Dystonia; 56 are open to participants now.
This study's planned enrollment of 20 is below the median of 32 across 181 interventional studies indexed under Dystonia.
Browse Dystonia studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Dystonia phenomenology improvement
a clinical assessment of dystonia will be conducted at each study visit using TWSTRS
Time frame: every six weeks during six months time
quality of life
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
brain plasticity
study of functional connectivity using functional magnetic resonance
Time frame: every six weeks during six months time
depression
depression scale (BECK)
Time frame: every six weeks during six months time
anxiety
anxiety scale (ZUNG)
Time frame: every six weeks during six months time
structural grey matter plasticity
brain study of morphometry using functional magnetic resonance
Time frame: every six weeks during six months time
structural white matter plasticity
tractography of brain areas using functional magnetic resonance
Time frame: every six weeks during six months time
kinematic assessment of dystonia severity
visit with optoelectronic system
Time frame: every six weeks during six months time
Plan to share: No
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi Onlus