Dystonic DisorderLabyDysNCT02882295
Validation of the Zigzag Tracking Task Test for the Evaluation of Handwriting Difficulties in Writer's Cramp
An observational study of Dystonic Disorder, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonic Disorder
- What is being tested?
- Validation of a handwriting scale
- Type of treatment
- Injection or infusion
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2016to 15 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients suffering from writer's cramp and healthy subjects, age and gender matched
Who may be able to join
- scholarship in French language, at least until 16 years old
- writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders)
- prescription of botulinum neurotoxin injection
- prescription de novo or absence of injection in the last 3 months
- informed consent
- medical insurance coverage
Who cannot join
- writing tremor
- -other neurological disease with effect on handwriting
- pain or traumatism of the upper limb, with effect on handwriting
- non-corrected visual disturbances
- patient living outside the region where the study will be held (Ile-de-France)
- participation in another research with a potential impact on evaluation criteria
- pregnant or breast feeding patient
- patient under judiciary protection
Trial locations and contacts
1 site in 1 country.
About this study
Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm.
Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy).
The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.
- Conditions
- Dystonic Disorder
- Being tested
- Validation of a handwriting scale
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of a handwriting scaleOther
| Study group | Role | What they receive |
|---|---|---|
| writer's cramp | patients assessed without, then with Botulinum Neurotoxin injections Receives: Other: Validation of a handwriting scale | |
| control | age and gender matched Receives: Other: Validation of a handwriting scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand-writing speed
speed and accuracy of handwriting
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start5 Jul 2016
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Why it stopped: recrutement difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystonic DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre BLETON, PhD, Study director, Fondation OPH A de RothschildSophie SANGLA, MD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882295
- Sponsor's protocol ID
- SSA_2016_10
- Acronym
- LabyDys
- Status last verified
- Apr 2022
- First submitted
- 24 Aug 2016
- Last updated
- 14 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Zigzag Tracking Task Test for the Evaluation of Handwriting Difficulties in Writer's Cramp
- ClinicalTrials.gov ID
- NCT02882295
- Acronym / sponsor ID
- LabyDys / SSA_2016_10
- Conditions
- Dystonic Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recrutement difficulties
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 29 Aug 2016 (estimated)
- 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 (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm.
Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy).
The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| writer's cramp | – | Other: Validation of a handwriting scalepatients assessed without, then with Botulinum Neurotoxin injections |
| control | – | Other: Validation of a handwriting scaleage and gender matched |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from writer's cramp and healthy subjects, age and gender matched
Key inclusion criteria (6 listed)
- scholarship in French language, at least until 16 years old
- writer's cramp (diagnostic confirmed by a neurologist specialized in movement disorders)
- prescription of botulinum neurotoxin injection
- prescription de novo or absence of injection in the last 3 months
- informed consent
Key exclusion criteria (8 listed)
- writing tremor
- -other neurological disease with effect on handwriting
- pain or traumatism of the upper limb, with effect on handwriting
- non-corrected visual disturbances
- patient living outside the region where the study will be held (Ile-de-France)
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 |
|---|---|---|
| Validation of a handwriting scale | Other | control, writer's cramp |
Primary outcome
hand-writing speed
Time frame: immediate
speed and accuracy of handwriting
Results and safety
The study was stopped early (reason given: recrutement difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
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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. This study is not recruiting at the moment.
Jean-Pierre BLETON, PhD study director
Fondation OPH A de Rothschild
Sophie SANGLA, MD principal investigator
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dystonic Disorder, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 14 Apr 2022. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: recrutement difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand-writing speed (time frame: immediate). 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 14 Apr 2022.