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

Phase 2

Recruiting

• Conditions: Writer's Cramp
• Interventions: Behavioral: motor training; Behavioral: mindfulness exercises

• Registration Number: NCT04611009
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-10
• Study Start: 2020-06-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-11-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
motor training	motor training	intervention: motor training
awareness training	mindfulness exercises	intervention: mindfulness exercises

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure	Change from baseline to month 4, 8, 12	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.

Secondary Outcome Measures

Name	Time	Method
Writer's Cramp Rating Scale	Change from baseline to month 4, 8, 12	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.
kinematic writing analysis	Change from baseline to month 4, 8, 12	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.
qualitative interviews	Change from baseline to month 4, 12	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.
writing during functional magnetic resonance imaging (fMRI)	Change from baseline to month 4, 8, 12	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.
Arm Dystonia Disability Scale	Change from baseline to month 4, 8, 12	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).
Serial Reaction Time Task during functional magnetic resonance imaging (fMRI)	Change from baseline to month 4, 8, 12	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.

Trial Locations

Locations (1)

Kiel University; 🇩🇪 Kiel, Schleswig-Holstein, Germany