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

Writer's Cramp Clinical Trial

Official title:

Treatment Effect and Relevance on Daily Life of a Video-supervised Sensorimotor Training Program and Its Influence on the Pathophysiology in Writer's Cramp

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611009
• Other study ID #: DE 579/17
• Status: Recruiting
• Phase: Phase 2
• Start date: June 26, 2020
• Est. completion date: May 2023

Study information

• Verified date: October 2020
• Source: University Hospital Schleswig-Holstein
• Contact: Kirsten E Zeuner, Prof. MD
• Phone: 0431-500-23801
• Email: k.zeuner[@]neurologie.uni-kiel.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: May 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Exclusion criteria for MRI:

• Cardiac pacemaker, electronic or metal implants

• pregnancy or suspected pregnancy

• severe ametropia, anxiety in small rooms

Related Conditions & MeSH terms

• Dystonic Disorders
• Muscle Cramp
• Writer's Cramp

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Kiel University	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Occupational Performance Measure	The Canadian Occupational Performance Measure will serve as the primary outcome measure. Patients grade their self-perceived performance and satisfaction of writing related occupations in daily life in respect to the goals they had identified and prioritized. The COPM ist patient centered end reflects the real life of the participants.	Change from baseline to month 4, 8, 12
Secondary	kinematic writing analysis	The kinematic handwriting analysis will be performed on a pressure sensitive digitizing tablet, that is connected to a laptop to measure movements of the pencil during writing. Regularity of writing will be calculated from this data. All subjects will write a standardized sentence and draw superimposed circles to characterize handwriting movements.	Change from baseline to month 4, 8, 12
Secondary	Writer's Cramp Rating Scale	The video based Writer's Cramp Rating Scale will serve as a secondary outcome parameter. The videos are rated by a blinded movement disorder specialist according to flexion / extension of arm / wrist / fingers during writing.	Change from baseline to month 4, 8, 12
Secondary	writing during functional magnetic resonance imaging (fMRI)	During this task participants will be instructed to a) write a sentence using an MR-compatible tablet and b) imagine writing in randomized order. The task is performed during a fMRI measurement. With the imaginary task artefacts are avoided and activation during movement planning will be investigated in the fMRI.	Change from baseline to month 4, 8, 12
Secondary	qualitative interviews	The purpose of the semi-structured qualitative interviews about the training procedures is to optimize the training and to differentiate between responders and non-responders. The interviews will be will be transcribed word-for-word and analyzed using the qualitative content analysis.	Change from baseline to month 4, 12
Secondary	Arm Dystonia Disability Scale	The Arm Dystonia Disability Scale will be applied to assess how dystonia interferes with manual activities during daily life (writing, buttoning, hygiene, eating, job or household).	Change from baseline to month 4, 8, 12
Secondary	Serial Reaction Time Task during functional magnetic resonance imaging (fMRI)	The Serial Reaction Time Task is a standardized method to investigate motor sequence learning and to induce cerebellar activation. We expect that abnormal cerebellar activity in patients compared to controls normalizes after training.	Change from baseline to month 4, 8, 12

External Links

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