DystoniaPRISMADYSNCT03270189
Effect of the Visual Information Change in Functional Dystonia
A study testing prism glasses in people with Dystonia and Dystonic Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Cervical dystonia occurring only during the writing task is a rare form for which there is no established treatment. Many authors agree that alteration of sensory integration is associated with dystonia. Read more about this study
- Who is it for?
- Ages 18 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia, Dystonic Disorders, Torticollis
- What is being tested?
- prism glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2017to 19 Sep 2022
- 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 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Case
- Presenting a cervical dystonia that occurs only during handwriting tasks, diagnosed by a neurologist specialised in movement disorders
- Being treated or not by injection of Botulinum Neurotoxin (but last injection > 3 months before the initial assessment)
- Control
- No cervical dystonia
- Same sex, age (± 5 years), socio-professional level and hand laterality as the cases
Who cannot join
- Case
- Cervical dystonia occuring in other circumstances than handwriting
- Neurological disease other than cervical dystonia (e.g. Parkinson's syndrome)
- Pain, trauma or pathology of the cervical spine of another cause than cervical dystonia and which have required medical or surgical treatment in the last 6 months preceding the initial assessment
- Control
- Cervical disorders requiring medical or surgical treatment in the last 6 months prior to the tests
- Neurological disease affecting the cervical region or the writing hand
- Uncorrected visual disorders
Trial locations and contacts
1 site in 1 country.
About this study
Cervical dystonia occurring only during the writing task is a rare form for which there is no established treatment. Many authors agree that alteration of sensory integration is associated with dystonia. Similar disturbances in the integration of oculomotor information could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such as handwriting. We hypothesize that orthoptic treatment by wearing prisms when writing (i) will reduce the abnormal posture of the head occurring whilst writing and remove the associated nuchal pain; (ii) the correction after a period of systematic wearing of the prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head position after the suppression of the prisms.
- Conditions
- Dystonia, Dystonic Disorders, Torticollis, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases
- Being tested
- prism glasses
- Medical subject headings
- Dystonia, Dystonic Disorders, Torticollis, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases, Dyskinesias, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prism glassesDevice
orthoptic treatment by wearing prisms when writing
| Study group | Role | What they receive |
|---|---|---|
| orthoptic treatment | Experimental | Patients with cervical dystonia occuring only during handwriting. Receives: Device: prism glasses |
| Controls | No intervention | Patients without cervical dystonia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of head movement occurring when writing
Difference of the angle measured with and without corrective prisms during the handwriting tasks
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start18 Sep 2017
- Primary completion19 Dec 2021
- Study completion19 Sep 2022
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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 chair, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270189
- Sponsor's protocol ID
- SSA_2016_23
- Acronym
- PRISMADYS
- Status last verified
- Feb 2023
- First submitted
- 29 Aug 2017
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Visual Information Change in Functional Dystonia
- ClinicalTrials.gov ID
- NCT03270189
- Acronym / sponsor ID
- PRISMADYS / SSA_2016_23
- Conditions
- Dystonia, Dystonic Disorders, Torticollis, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 19 Dec 2021 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 1 Sep 2017 (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.
Cervical dystonia occurring only during the writing task is a rare form for which there is no established treatment. Many authors agree that alteration of sensory integration is associated with dystonia. Similar disturbances in the integration of oculomotor information could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such as handwriting. We hypothesize that orthoptic treatment by wearing prisms when writing (i) will reduce the abnormal posture of the head occurring whilst writing and remove the associated nuchal pain; (ii) the correction after a period of systematic wearing of the prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head position after the suppression of the prisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orthoptic treatment | Experimental | Device: prism glassesPatients with cervical dystonia occuring only during handwriting. |
| Controls | No intervention | –Patients without cervical dystonia. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Case
- Presenting a cervical dystonia that occurs only during handwriting tasks, diagnosed by a neurologist specialised in movement disorders
- Being treated or not by injection of Botulinum Neurotoxin (but last injection > 3 months before the initial assessment)
- Control
- No cervical dystonia
Key exclusion criteria (8 listed)
- Case
- Cervical dystonia occuring in other circumstances than handwriting
- Neurological disease other than cervical dystonia (e.g. Parkinson's syndrome)
- Pain, trauma or pathology of the cervical spine of another cause than cervical dystonia and which have required medical or surgical treatment in the last 6 months preceding the initial assessment
- Control
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 |
|---|---|---|
| prism glassesorthoptic treatment by wearing prisms when writing | Device | orthoptic treatment |
Primary outcome
measure of head movement occurring when writing
Time frame: 3 months
Difference of the angle measured with and without corrective prisms during the handwriting tasks
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
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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 chair
Fondation Ophtalmologique Adolphe 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 prism glasses in people with Dystonia and Dystonic Disorders, 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 Feb 2023. 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: lack of recruitment). 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?
measure of head movement occurring when writing (time frame: 3 months). 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 Feb 2023.