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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03247868
Acronym
SPRInt
Enrollment
20
Registered
2017-08-14
Start date
2016-03-16
Completion date
2018-06-30
Last updated
2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Dystonia,Primary

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.

Interventions

COMBINATION_PRODUCTBotulinum Toxin+SPRInt

Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt)

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dystonia phenomenology improvementevery six weeks during six months timea clinical assessment of dystonia will be conducted at each study visit using TWSTRS

Secondary

MeasureTime frameDescription
brain plasticityevery six weeks during six months timestudy of functional connectivity using functional magnetic resonance
depressionevery six weeks during six months timedepression scale (BECK)
anxietyevery six weeks during six months timeanxiety scale (ZUNG)
quality of lifeevery six weeks during six months timea clinical assessment of dystonia severity will be conducted at each study visit using quality of life scale (EQ5D5L)
structural white matter plasticityevery six weeks during six months timetractography of brain areas using functional magnetic resonance
kinematic assessment of dystonia severityevery six weeks during six months timevisit with optoelectronic system
structural grey matter plasticityevery six weeks during six months timebrain study of morphometry using functional magnetic resonance

Countries

Italy

Contacts

Primary ContactAnna Castagna, MD
acastagna@dongnocchi.it+39 02 40308075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026