A Phase 2 interventional study of motor training and mindfulness exercises in Writer's Cramp, sponsored by University Hospital Schleswig-Holstein. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University Hospital Schleswig-Holstein · Phase 2, Interventional, and Treatment
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.
95 studies on the registry are indexed under Dystonic Disorders; 19 are open to participants now.
This study's planned enrollment of 54 is above the median of 24 across 45 interventional studies indexed under Dystonic Disorders.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for MRI:
intervention: motor training
Behavioral: motor training
intervention: mindfulness exercises
Behavioral: mindfulness exercises
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.
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.
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.
Time frame: Change from baseline to month 4, 8, 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Change from baseline to month 4, 8, 12
Plan to share: No
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