A Multimodal Approach to Cervical Dystonia Treatment With NCT03247868

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT03247868
Other study ID #	SPRIntFdG
Secondary ID
Status	Recruiting
Phase	N/A
First received	July 27, 2017
Last updated	August 11, 2017
Start date	March 16, 2016
Est. completion date	June 30, 2018

Study information
Verified date	July 2017
Source	Fondazione Don Carlo Gnocchi Onlus
Contact	Anna Castagna, MD
Phone	+39 02 40308075
Email	acastagna[@]dongnocchi.it
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Recruiting
Enrollment	20
Est. completion date	June 30, 2018
Est. primary completion date	March 28, 2018
Accepts healthy volunteers	No
Gender	All
Age group	18 Years to 80 Years
Eligibility	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 Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• Botulinum Toxin+SPRInt
Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt)

Locations
Country	Name	City	State
Italy	IRCCS Fondazione Don Gnocchi	Milano	MI

Sponsors *(1)*
Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy,

References & Publications (11)

Albanese A, Bhatia K, Bressman SB, Delong MR, Fahn S, Fung VS, Hallett M, Jankovic J, Jinnah HA, Klein C, Lang AE, Mink JW, Teller JK. Phenomenology and classification of dystonia: a consensus update. Mov Disord. 2013 Jun 15;28(7):863-73. doi: 10.1002/mds.25475. Epub 2013 May 6. Review. — View Citation

Boccagni C, Carpaneto J, Micera S, Bagnato S, Galardi G. Motion analysis in cervical dystonia. Neurol Sci. 2008 Dec;29(6):375-81. doi: 10.1007/s10072-008-1033-z. Epub 2008 Nov 29. — View Citation

Currà A, Trompetto C, Abbruzzese G, Berardelli A. Central effects of botulinum toxin type A: evidence and supposition. Mov Disord. 2004 Mar;19 Suppl 8:S60-4. Review. — View Citation

De Pauw J, Van der Velden K, Meirte J, Van Daele U, Truijen S, Cras P, Mercelis R, De Hertogh W. The effectiveness of physiotherapy for cervical dystonia: a systematic literature review. J Neurol. 2014 Oct;261(10):1857-65. doi: 10.1007/s00415-013-7220-8. Epub 2014 Jan 12. Review. — View Citation

Delnooz CC, Pasman JW, Beckmann CF, van de Warrenburg BP. Task-free functional MRI in cervical dystonia reveals multi-network changes that partially normalize with botulinum toxin. PLoS One. 2013 May 1;8(5):e62877. doi: 10.1371/journal.pone.0062877. Print 2013. — View Citation

Delnooz CC, Pasman JW, van de Warrenburg BP. Dynamic cortical gray matter volume changes after botulinum toxin in cervical dystonia. Neurobiol Dis. 2015 Jan;73:327-33. doi: 10.1016/j.nbd.2014.10.013. Epub 2014 Oct 28. — View Citation

Kitago T, Krakauer JW. Motor learning principles for neurorehabilitation. Handb Clin Neurol. 2013;110:93-103. doi: 10.1016/B978-0-444-52901-5.00008-3. Review. — View Citation

Prudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11. Review. — View Citation

Simpson DM, Hallett M, Ashman EJ, Comella CL, Green MW, Gronseth GS, Armstrong MJ, Gloss D, Potrebic S, Jankovic J, Karp BP, Naumann M, So YT, Yablon SA. Practice guideline update summary: Botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016 May 10;86(19):1818-26. doi: 10.1212/WNL.0000000000002560. Epub 2016 Apr 18. — View Citation

van den Dool J, Visser B, Koelman JH, Engelbert RH, Tijssen MA. Cervical dystonia: effectiveness of a standardized physical therapy program; study design and protocol of a single blind randomized controlled trial. BMC Neurol. 2013 Jul 15;13:85. doi: 10.1186/1471-2377-13-85. — View Citation

Walter U, Dressler D. Ultrasound-guided botulinum toxin injections in neurology: technique, indications and future perspectives. Expert Rev Neurother. 2014 Aug;14(8):923-36. doi: 10.1586/14737175.2014.936387. Epub 2014 Jul 21. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome
Type	Measure	Description	Time frame
Primary	Dystonia phenomenology improvement	a clinical assessment of dystonia will be conducted at each study visit using TWSTRS	every six weeks during six months time
Secondary	quality of life	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
Secondary	brain plasticity	study of functional connectivity using functional magnetic resonance	every six weeks during six months time
Secondary	depression	depression scale (BECK)	every six weeks during six months time
Secondary	anxiety	anxiety scale (ZUNG)	every six weeks during six months time
Secondary	structural grey matter plasticity	brain study of morphometry using functional magnetic resonance	every six weeks during six months time
Secondary	structural white matter plasticity	tractography of brain areas using functional magnetic resonance	every six weeks during six months time
Secondary	kinematic assessment of dystonia severity	visit with optoelectronic system	every six weeks during six months time

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

Clinical Trial Details — Status: Recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

References & Publications (11)

Outcome