Dystonic DisorderFFM_CTNCT03797638
Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects
A study testing Finger Force Manipuladum (FFM) in people with Dystonic Disorder and Focal Dystonia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Writer's cramp is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dystonic Disorder, Focal Dystonia, Writer's Cramp
- What is being tested?
- Finger Force Manipuladum (FFM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2018to 19 Jul 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with writer's cramp and writing speed <140 letters / min
- Writer's cramp focal dystonia specific to the task of writing
- Patient treated or not with botulinum toxin injection
- Person having attended school in French
- Non inclusion criteria for patients with writer's cramp
- Patients whose writer's cramp has no impact on the handwriting and has kept a writing speed> 140 letters per minute.
Show all 20Show fewer
- Tremor of writing
- Neurological condition other than writer's cramp (eg Parkinson's syndrome)
- Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up
- •> 18 years old
- Without writer's cramp
- Person having attended school in French
- Non inclusion criteria for control subjects
- Tremor of writing
- Neurological condition other than writer's cramp (eg Parkinson's syndrome)
- Pain, trauma or pathology of the upper limb of the writing member other than the writer's cramp who required medical or surgical treatment in the last 6 months preceding the initial check-up
- Matching criteria between cases and control patients
- Age (± 5 years)
- Gender
- Hand writing
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Writer's cramp is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. Patients with Writer's cramp also have difficulty in fine control of grip force.
The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by each fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Different tasks have been developed to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.
Read more
The aim of this study is to assess if developed tasks allow to precisely characterize writer's cramp condition in terms of abilities aforementioned.
To do so, performance of 20 writer's cramp patients in the developed task will be compared with performance of 20 control participants (matched in age, sex and writing hand) in the same tasks.
- Conditions
- Dystonic Disorder, Focal Dystonia, Writer's Cramp
- Being tested
- Finger Force Manipuladum (FFM)
- Keywords
- Dystonic Disorder, Focal Dystonia, Writer's Cramp
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger Force Manipuladum (FFM)Device
Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with writer's cramp | Experimental | Patients with writer's cramp Receives: Device: Finger Force Manipuladum (FFM) |
| Control subjects | Other | Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing Receives: Device: Finger Force Manipuladum (FFM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual dexterity by the FFM
Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Oct 2018
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre BLETON, PhD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797638
- Sponsor's protocol ID
- SSA_2018_4
- Acronym
- FFM_CT
- Status last verified
- Jun 2021
- First submitted
- 7 Jan 2019
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects
- ClinicalTrials.gov ID
- NCT03797638
- Acronym / sponsor ID
- FFM_CT / SSA_2018_4
- Conditions
- Dystonic Disorder, Focal Dystonia, Writer's Cramp
- Keywords
- Dystonic Disorder, Focal Dystonia, Writer's Cramp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 9 Jan 2019 (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 a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. Patients with Writer's cramp also have difficulty in fine control of grip force.
The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by each fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Different tasks have been developed to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.
The aim of this study is to assess if developed tasks allow to precisely characterize writer's cramp condition in terms of abilities aforementioned.
To do so, performance of 20 writer's cramp patients in the developed task will be compared with performance of 20 control participants (matched in age, sex and writing hand) in the same tasks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with writer's cramp | Experimental | Device: Finger Force Manipuladum (FFM)Patients with writer's cramp |
| Control subjects | Other | Device: Finger Force Manipuladum (FFM)Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient with writer's cramp and writing speed <140 letters / min
- Writer's cramp focal dystonia specific to the task of writing
- Patient treated or not with botulinum toxin injection
- Person having attended school in French
- Non inclusion criteria for patients with writer's cramp
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Finger Force Manipuladum (FFM)Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed. | Device | Control subjects, Patients with writer's cramp |
Primary outcome
Manual dexterity by the FFM
Time frame: Inclusion
Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Deep Brain Stimulation Surgery for Movement Disorders
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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 principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finger Force Manipuladum (FFM) in people with Dystonic Disorder and Focal Dystonia, 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 20 inclusion and 0 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: finished, as of the sponsor's last update on 22 Jun 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Manual dexterity by the FFM (time frame: Inclusion). 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 22 Jun 2021.