Writer's CrampPhase 2NCT04611009
Video-supervised Motor and Awareness Training in Writer's Cramp
A Phase 2 study testing motor training and mindfulness exercises in people with Writer's Cramp, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Writer's Cramp
- What is being tested?
- motor training and mindfulness exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jun 2020to 1 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Kiel University
Kiel, Schleswig-Holstein, 24105
Kirsten E Zeuner, Prof. MD, 0431-500-23801 ext. 0049, k.zeuner@neurologie.uni-kiel.de
About this study
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
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
- Being tested
- motor training, mindfulness exercises
- Keywords
- dystonia, training, kinematic writing analysis, COPM, functional magnetic resonance imaging
- Medical subject headings
- Dystonic Disorders, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor trainingBehavioural
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.
mindfulness exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| motor training | Experimental | intervention: motor training Receives: Behavioral: motor training |
| awareness training | Active comparator | intervention: mindfulness exercises Receives: Behavioral: mindfulness exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to month 4, 8, 12
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Change from baseline to month 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start26 Jun 2020
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Writer's CrampStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, double blinded trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten E Zeuner, Prof. MD, Principal investigator, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611009
- Sponsor's protocol ID
- DE 579/17
- Status last verified
- Dec 2024
- First submitted
- 10 Jun 2020
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04611009
- Acronym / sponsor ID
- DE 579/17
- Conditions
- Writer's Cramp
- Keywords
- dystonia, training, kinematic writing analysis, COPM, functional magnetic resonance imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, controlled, double blinded trial
| Arm | Type | Receives |
|---|---|---|
| motor training | Experimental | Behavioral: motor trainingintervention: motor training |
| awareness training | Active comparator | Behavioral: mindfulness exercisesintervention: mindfulness exercises |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor trainingIn 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. | Behavioural | motor training |
| mindfulness exercisesThe awareness training will contain mindfulness exercises. The goal is to consciously experience the here and now in sensual perception of oneself and the environment. | Behavioural | awareness training |
Primary outcome
Canadian Occupational Performance Measure
Time frame: Change from baseline to month 4, 8, 12
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.
6 secondary outcomes
kinematic writing analysis
Time frame: Change from baseline to month 4, 8, 12
Writer's Cramp Rating Scale
Time frame: Change from baseline to month 4, 8, 12
writing during functional magnetic resonance imaging (fMRI)
Time frame: Change from baseline to month 4, 8, 12
qualitative interviews
Time frame: Change from baseline to month 4, 12
Arm Dystonia Disability Scale
Time frame: Change from baseline to month 4, 8, 12
Serial Reaction Time Task during functional magnetic resonance imaging (fMRI)
Time frame: Change from baseline to month 4, 8, 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Writer's Cramp
Not yet recruiting
VTS Sensorimotor Neuromodulation in WC
Writer's Cramp, Dystonias
RecruitingObservational study
Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsten E Zeuner, Prof. MD principal investigator
University of Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing motor training and mindfulness exercises in people with Writer's Cramp, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten E Zeuner, Prof. MD (0431-500-23801 ext. 0049, k.zeuner@neurologie.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (time frame: Change from baseline to month 4, 8, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.