Video-supervised Motor and Awareness Training in Writer's Cramp

NCT ID: NCT04611009

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-26

Study Completion Date

2027-01-01

Brief Summary

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Writer's cramp is the most common task-specific dystonia. It is characterized by involuntary co-contraction of antagonistic muscles during writing. This disabling condition may force patients to give up their occupation. In this study the efficacy of a twelve months long-term training in patients with writer's cramp will be investigated. Two different programs will be offered: The first one will consist of a sensorimotor, the second one of an awareness training. All patients will benefit from video-based supervision with the aim to establish a practice-oriented therapeutic approach that will be available to all patients independently of their home location. The treatment effect will be measured primary with the patient-centered Canadian Occupational Performance Measure (COPM) and secondary with clinical scales to assess the clinical efficacy and everyday constraints. Writing will be assessed with a computer-based kinematic writing analysis. To evaluate the influence on the brain network, several functional magnetic resonance imaging (fMRI) evaluations will be performed. This project is of minimal risk without negative side effects from the training. The risks for the MRI experiment are equal to a non-contrast standard MRI investigation.

Detailed Description

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Conditions

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Writer's Cramp

Keywords

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dystonia training kinematic writing analysis COPM functional magnetic resonance imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, controlled, double blinded trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants are blinded towards their participation in the two arms Clinical scales, kinematic writing anlysis and functional MRI will be analyzed by persons, who are blinded to the type of training group allocation

Study Groups

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motor training

intervention: motor training

Group Type EXPERIMENTAL

motor training

Intervention Type BEHAVIORAL

In the sensorimotor training program task-specific and non-task specific aspects will be combined. It will start with assignments to improve general finger and wrist movements. After four weeks more specific writing exercises will be added.

awareness training

intervention: mindfulness exercises

Group Type ACTIVE_COMPARATOR

mindfulness exercises

Intervention Type BEHAVIORAL

The awareness training will contain mindfulness exercises. The goal is to consciously experience the here and now in sensual perception of oneself and the environment.

Interventions

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motor training

In the sensorimotor training program task-specific and non-task specific aspects will be combined. It will start with assignments to improve general finger and wrist movements. After four weeks more specific writing exercises will be added.

Intervention Type BEHAVIORAL

mindfulness exercises

The awareness training will contain mindfulness exercises. The goal is to consciously experience the here and now in sensual perception of oneself and the environment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Right handed idiopathic WC according to standardized criteria (simple and complex WC, any dystonic posture (including flexion, extension, pronation, supination))
* able to participate in video-calls

Exclusion Criteria

* Additional neurological or psychiatric diseases
* left-handed patients
* last botulinum toxin treatment \<3 months, remaining weakness from the last injection
* concomitant use of anticholinergics or sedating medication


* Cardiac pacemaker, electronic or metal implants
* pregnancy or suspected pregnancy
* severe ametropia, anxiety in small rooms
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirsten E Zeuner, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Kiel University

Locations

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Kiel University

Kiel, Schleswig-Holstein, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Kirsten E Zeuner, Prof. MD

Role: CONTACT

Phone: 0431-500-23801

Email: [email protected]

Arne Knutzen, M.Sc. OT

Role: CONTACT

Phone: 0431-500-23801

Email: [email protected]

Facility Contacts

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Kirsten E Zeuner, Prof. MD

Role: primary

Related Links

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http://pubmed.ncbi.nlm.nih.gov/19406309/

Baur B, et.al. Effects of modified pen grip and handwriting training on writer's cramp. Arch Phys Med Rehabil 2009;90(5):867-875.

http://pubmed.ncbi.nlm.nih.gov/20562399/

Bleton JP, Vidailhet M, Bourdain F, Ducorps A, Schwartz D, et al. Somatosensory cortical remodelling after rehabilitation and clinical benefit of in writer's cramp. J Neurol Neurosurg Psychiatry 2011;82(5):574-577.

http://pubmed.ncbi.nlm.nih.gov/22328061/

Castrop F, Dresel C, Hennenlotter A, Zimmer C, Haslinger B. Basal ganglia-premotor dysfunction during movement imagination in writer's cramp. Mov Disord 2012;27(11):1432-1439.

http://pubmed.ncbi.nlm.nih.gov/22113948/

Delnooz CC, Helmich RC, Medendorp WP, Van de Warrenburg BP, Toni I. Writer's cramp: increased dorsal premotor activity during intended writing. Hum Brain Mapp 2013;34(3):613-625.

http://pubmed.ncbi.nlm.nih.gov/27466043/

Gallea C, Horovitz SG, Najee-Ullah M, Hallett M. Impairment of a parieto-premotor network specialized for handwriting in writer's cramp. Hum Brain Mapp 2016;37(12):4363-4375.

http://pubmed.ncbi.nlm.nih.gov/20708692/

Granert O, Peller M, Gaser C, Groppa S, Hallett M, Knutzen A, Deuschl G, Zeuner KE, Siebner HR. Manual activity shapes structure and function in contralateral human motor hand area. Neuroimage 2011;54(1):32-41.

http://pubmed.ncbi.nlm.nih.gov/16859794/

Hallett M. Pathophysiology of writer's cramp. Hum Mov Sci 2006;25(4-5):454-463.

http://pubmed.ncbi.nlm.nih.gov/28081451/

Planton S, Longcamp M, Peran P, Demonet JF, Jucla M. How specialized are writing-specific brain regions? An fMRI study of writing, drawing and oral spelling. Cortex 2017;88:66-80.

http://pubmed.ncbi.nlm.nih.gov/29868443/

Rothkirch I, Granert O, Knutzen A, Wolff S, et al. Dynamic causal modeling revealed dysfunctional effective connectivity in both, the cortico-basal-ganglia and the cerebello-cortical motor network in writers' cramp. Neuroimage Clin 2018;18:149-159.

http://pubmed.ncbi.nlm.nih.gov/27734238/

Shakkottai VG, Batla A, Bhatia K , Dauer WT, Dresel C, et al. Current Opinions and Areas of Consensus on the Role of the Cerebellum in Dystonia. Cerebellum 2017;16(2):577-594.

http://pubmed.ncbi.nlm.nih.gov/28039522/

Stahl CM, Frucht SJ. Focal task specific dystonia: a review and update. J Neurol 2017;264(7):1536-1541.

http://pubmed.ncbi.nlm.nih.gov/15486996/

Zeuner KE, Shill HA, Sohn YH, Molloy FM, Thornton BC, Dambrosia JM, Hallett M. Motor training as treatment in focal hand dystonia. Mov Disord 2005;20(3):335-341.

http://pubmed.ncbi.nlm.nih.gov/17230462/

Zeuner KE, Peller M, Knutzen A, et al. How to assess motor impairment in writer's cramp. Mov Disord 2007;22(8):1102-1109.

http://pubmed.ncbi.nlm.nih.gov/18356588/

Zeuner KE, Molloy FM. Abnormal reorganization in focal hand dystonia-sensory and motor training programs to retrain cortical function. NeuroRehabilitation 2008;23(1):43-53.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4149415/

Zeuner KE, Peller M, Knutzen A, Hallett M, Deuschl G, Siebner HR. Motor re-training does not need to be task specific to improve writer's cramp. Mov Disord 2008;23(16):2319-2327.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4309880/

Zeuner KE, Knutzen A, Granert O, et al. Increased volume and impaired function: the role of the basal ganglia in writer's cramp. Brain Behav 2015;5(2):e00301.

Other Identifiers

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DE 579/17

Identifier Type: -

Identifier Source: org_study_id