Clinical trial NCT04611009: Video-supervised Motor and Awareness Training in Writer's Cramp
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Writer's Cramp
Keywords: dystonia
training
kinematic writing analysis
COPM
functional magnetic resonance imaging
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, double blinded trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: Change from baseline to month 4, 8, 12
Secondary outcomes:
measure: kinematic writing analysis
timeFrame: Change from baseline to month 4, 8, 12
measure: Writer's Cramp Rating Scale
timeFrame: Change from baseline to month 4, 8, 12
measure: writing during functional magnetic resonance imaging (fMRI)
timeFrame: Change from baseline to month 4, 8, 12
measure: qualitative interviews
timeFrame: Change from baseline to month 4, 12
measure: Arm Dystonia Disability Scale
timeFrame: Change from baseline to month 4, 8, 12
measure: Serial Reaction Time Task during functional magnetic resonance imaging (fMRI)
timeFrame: Change from baseline to month 4, 8, 12
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Kiel University
state: Schleswig-Holstein
Study officials:
affiliation: Kiel University
name: Kirsten E Zeuner, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: