A Multimodal Approach to Cervical Dystonia Treatment With Association of Botulinum Toxin and Motor Learning Techniques (SPRInt)
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| ClinicalTrials.gov Identifier: NCT03247868 |
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Recruitment Status : Unknown
Verified July 2017 by Fondazione Don Carlo Gnocchi Onlus.
Recruitment status was: Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Dystonia,Primary | Combination Product: Botulinum Toxin+SPRInt | Not Applicable |
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:
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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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | March 16, 2016 |
| Estimated Primary Completion Date : | March 28, 2018 |
| Estimated Study Completion Date : | June 30, 2018 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Combination Product: Botulinum Toxin+SPRInt
Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt) |
- 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
- 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)
- brain plasticity [ Time Frame: every six weeks during six months time ]study of functional connectivity using functional magnetic resonance
- depression [ Time Frame: every six weeks during six months time ]depression scale (BECK)
- anxiety [ Time Frame: every six weeks during six months time ]anxiety scale (ZUNG)
- structural grey matter plasticity [ Time Frame: every six weeks during six months time ]brain study of morphometry using functional magnetic resonance
- structural white matter plasticity [ Time Frame: every six weeks during six months time ]tractography of brain areas using functional magnetic resonance
- kinematic assessment of dystonia severity [ Time Frame: every six weeks during six months time ]visit with optoelectronic system
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247868
| Contact: Anna Castagna, MD | +39 02 40308075 | acastagna@dongnocchi.it |
| Italy | |
| IRCCS Fondazione Don Gnocchi | Recruiting |
| Milano, MI, Italy, 20148 | |
| Contact: Anna Castagna, MD +3902 40308075 acastagna@dongnocchi.it | |
| Principal Investigator: | Anna Castagna, MD | IRCCS Fondazione Don Gnocchi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fondazione Don Carlo Gnocchi Onlus |
| ClinicalTrials.gov Identifier: | NCT03247868 |
| Other Study ID Numbers: |
SPRIntFdG |
| First Posted: | August 14, 2017 Key Record Dates |
| Last Update Posted: | August 14, 2017 |
| Last Verified: | July 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Dystonia Dystonic Disorders Torticollis Dyskinesias Neurologic Manifestations Nervous System Diseases Movement Disorders Central Nervous System Diseases |
Botulinum Toxins Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |