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

NCT04611009 | Recruiting Phase 2

• 1 other identifier: DE 579/17
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Writer's Cramp

Keywords

dystonia; training; kinematic writing analysis; COPM; functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• kinematic writing analysis

  Change from baseline to month 4, 8, 12

• Writer's Cramp Rating Scale

  Change from baseline to month 4, 8, 12

• writing during functional magnetic resonance imaging (fMRI)

  Change from baseline to month 4, 8, 12

• qualitative interviews

  Change from baseline to month 4, 12

• Arm Dystonia Disability Scale

  Change from baseline to month 4, 8, 12

Study Arms (2)

motor training

EXPERIMENTAL

intervention: motor training

Behavioral: motor training

awareness training

ACTIVE COMPARATOR

intervention: mindfulness exercises

Behavioral: mindfulness exercises

Interventions

motor training BEHAVIORAL

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.

motor training

mindfulness exercises BEHAVIORAL

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.

awareness training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Cardiac pacemaker, electronic or metal implants
• pregnancy or suspected pregnancy
• severe ametropia, anxiety in small rooms

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Kiel University

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Related Links

• Baur B, et.al. Effects of modified pen grip and handwriting training on writer's cramp. Arch Phys Med Rehabil 2009;90(5):867-875.
• Bleton JP, Vidailhet M, Bourdain F, Ducorps A, Schwartz D, et al. Somatosensory cortical remodelling after rehabilitation and clinical benefit of in writer's cramp. J Neurol Neurosurg Psychiatry 2011;82(5):574-577.
• Castrop F, Dresel C, Hennenlotter A, Zimmer C, Haslinger B. Basal ganglia-premotor dysfunction during movement imagination in writer's cramp. Mov Disord 2012;27(11):1432-1439.
• Delnooz CC, Helmich RC, Medendorp WP, Van de Warrenburg BP, Toni I. Writer's cramp: increased dorsal premotor activity during intended writing. Hum Brain Mapp 2013;34(3):613-625.
• Gallea C, Horovitz SG, Najee-Ullah M, Hallett M. Impairment of a parieto-premotor network specialized for handwriting in writer's cramp. Hum Brain Mapp 2016;37(12):4363-4375.
• Granert O, Peller M, Gaser C, Groppa S, Hallett M, Knutzen A, Deuschl G, Zeuner KE, Siebner HR. Manual activity shapes structure and function in contralateral human motor hand area. Neuroimage 2011;54(1):32-41.
• Hallett M. Pathophysiology of writer's cramp. Hum Mov Sci 2006;25(4-5):454-463.
• Planton S, Longcamp M, Peran P, Demonet JF, Jucla M. How specialized are writing-specific brain regions? An fMRI study of writing, drawing and oral spelling. Cortex 2017;88:66-80.
• Rothkirch I, Granert O, Knutzen A, Wolff S, et al. Dynamic causal modeling revealed dysfunctional effective connectivity in both, the cortico-basal-ganglia and the cerebello-cortical motor network in writers' cramp. Neuroimage Clin 2018;18:149-159.
• Shakkottai VG, Batla A, Bhatia K , Dauer WT, Dresel C, et al. Current Opinions and Areas of Consensus on the Role of the Cerebellum in Dystonia. Cerebellum 2017;16(2):577-594.
• Stahl CM, Frucht SJ. Focal task specific dystonia: a review and update. J Neurol 2017;264(7):1536-1541.
• Zeuner KE, Shill HA, Sohn YH, Molloy FM, Thornton BC, Dambrosia JM, Hallett M. Motor training as treatment in focal hand dystonia. Mov Disord 2005;20(3):335-341.
• Zeuner KE, Peller M, Knutzen A, et al. How to assess motor impairment in writer's cramp. Mov Disord 2007;22(8):1102-1109.
• Zeuner KE, Molloy FM. Abnormal reorganization in focal hand dystonia-sensory and motor training programs to retrain cortical function. NeuroRehabilitation 2008;23(1):43-53.
• Zeuner KE, Peller M, Knutzen A, Hallett M, Deuschl G, Siebner HR. Motor re-training does not need to be task specific to improve writer's cramp. Mov Disord 2008;23(16):2319-2327.
• Zeuner KE, Knutzen A, Granert O, et al. Increased volume and impaired function: the role of the basal ganglia in writer's cramp. Brain Behav 2015;5(2):e00301.

MeSH Terms

Conditions

Dystonic Disorders; Dystonia

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsten E Zeuner, Prof. MD

  Kiel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten E Zeuner, Prof. MD

CONTACT

0431-500-23801; k.zeuner@neurologie.uni-kiel.de

Arne Knutzen, M.Sc. OT

CONTACT

0431-500-23801; a.knutzen@neurologie.uni-kiel.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded towards their participation in the two arms Clinical scales, kinematic writing anlysis and functional MRI will be analyzed by persons, who are blinded to the type of training group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, controlled, double blinded trial

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: November 2, 2020
• Study Start: June 26, 2020
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)