Video-supervised Motor and Awareness Training in Writer's Cramp
Primary Purpose
Writer's Cramp
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
motor training
mindfulness exercises
Sponsored by
About this trial
This is an interventional treatment trial for Writer's Cramp focused on measuring dystonia, training, kinematic writing analysis, COPM, functional magnetic resonance imaging
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
Sites / Locations
- Kiel UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
motor training
awareness training
Arm Description
intervention: motor training
intervention: mindfulness exercises
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
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.
Full Information
NCT ID
NCT04611009
First Posted
June 10, 2020
Last Updated
October 26, 2020
Sponsor
University Hospital Schleswig-Holstein
1. Study Identification
Unique Protocol Identification Number
NCT04611009
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Schleswig-Holstein
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Writer's Cramp
Keywords
dystonia, training, kinematic writing analysis, COPM, functional magnetic resonance imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled, double blinded trial
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
motor training
Arm Type
Experimental
Arm Description
intervention: motor training
Arm Title
awareness training
Arm Type
Active Comparator
Arm Description
intervention: mindfulness exercises
Intervention Type
Behavioral
Intervention Name(s)
motor training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mindfulness exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure
Description
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
Secondary Outcome Measure Information:
Title
kinematic writing analysis
Description
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
Title
Writer's Cramp Rating Scale
Description
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
Title
writing during functional magnetic resonance imaging (fMRI)
Description
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
Title
qualitative interviews
Description
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
Title
Arm Dystonia Disability Scale
Description
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
Title
Serial Reaction Time Task during functional magnetic resonance imaging (fMRI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten E Zeuner, Prof. MD
Phone
0431-500-23801
Ext
0049
Email
k.zeuner@neurologie.uni-kiel.de
First Name & Middle Initial & Last Name or Official Title & Degree
Arne Knutzen, M.Sc. OT
Phone
0431-500-23801
Ext
0049
Email
a.knutzen@neurologie.uni-kiel.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten E Zeuner, Prof. MD
Organizational Affiliation
Kiel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kiel University
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten E Zeuner, Prof. MD
Phone
0431-500-23801
Ext
0049
Email
k.zeuner@neurologie.uni-kiel.de
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/19406309/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/20562399/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/22328061/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/22113948/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/27466043/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/20708692/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/16859794/
Description
Hallett M. Pathophysiology of writer's cramp. Hum Mov Sci 2006;25(4-5):454-463.
URL
http://pubmed.ncbi.nlm.nih.gov/28081451/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/29868443/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/27734238/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/28039522/
Description
Stahl CM, Frucht SJ. Focal task specific dystonia: a review and update. J Neurol 2017;264(7):1536-1541.
URL
http://pubmed.ncbi.nlm.nih.gov/15486996/
Description
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.
URL
http://pubmed.ncbi.nlm.nih.gov/17230462/
Description
Zeuner KE, Peller M, Knutzen A, et al. How to assess motor impairment in writer's cramp. Mov Disord 2007;22(8):1102-1109.
URL
http://pubmed.ncbi.nlm.nih.gov/18356588/
Description
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.
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4149415/
Description
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.
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4309880/
Description
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.
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Video-supervised Motor and Awareness Training in Writer's Cramp
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