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

University Hospital Schleswig-Holstein (UKSH)

Status and phase: Enrolling; Phase 2

Conditions: Writer's Cramp

Treatments: Behavioral: mindfulness exercises; Behavioral: motor training

Study type: Interventional

Funder types: Other

Identifiers

NCT04611009

DE 579/17

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

motor training

Experimental group

Description:

intervention: motor training

Treatment:

Behavioral: motor training

awareness training

Active Comparator group

Description:

intervention: mindfulness exercises

Treatment:

Behavioral: mindfulness exercises