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

Study Overview
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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.

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

Conditions
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Writer's Cramp

Intervention / Treatment
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* Behavioral: motor training
* Behavioral: mindfulness exercises


Participation Criteria
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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 Exclusion criteria for MRI: Cardiac pacemaker, electronic or metal implants pregnancy or suspected pregnancy severe ametropia, anxiety in small rooms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, controlled, double blinded trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: motor training<br>intervention: motor training | Behavioral: motor training<br>* 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.<br>|
| Active Comparator: awareness training<br>intervention: mindfulness exercises | Behavioral: mindfulness exercises<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dystonia, training, kinematic writing analysis, COPM, functional magnetic resonance imaging