Effect of the Visual Information Change in Functional Dystonia (PRISMADYS)
Primary Purpose
Dystonia, Dystonic Disorders, Torticollis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prism glasses
Sponsored by
About this trial
This is an interventional treatment trial for Dystonia
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- Fondation Ophtalmique Adolphe de Rothschild
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
orthoptic treatment
Controls
Arm Description
Patients with cervical dystonia occuring only during handwriting.
Patients without cervical dystonia.
Outcomes
Primary Outcome Measures
measure of head movement occurring when writing
Difference of the angle measured with and without corrective prisms during the handwriting tasks
Secondary Outcome Measures
Full Information
NCT ID
NCT03270189
First Posted
August 29, 2017
Last Updated
February 11, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT03270189
Brief Title
Effect of the Visual Information Change in Functional Dystonia
Acronym
PRISMADYS
Official Title
Effect of the Visual Information Change in Functional Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
December 19, 2021 (Actual)
Study Completion Date
September 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia, Dystonic Disorders, Torticollis, Movement Disorders, Central Nervous System Diseases, Nervous System Diseases, Dyskinesias, Neurologic Manifestations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
orthoptic treatment
Arm Type
Experimental
Arm Description
Patients with cervical dystonia occuring only during handwriting.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Patients without cervical dystonia.
Intervention Type
Device
Intervention Name(s)
prism glasses
Intervention Description
orthoptic treatment by wearing prisms when writing
Primary Outcome Measure Information:
Title
measure of head movement occurring when writing
Description
Difference of the angle measured with and without corrective prisms during the handwriting tasks
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Bleton, PhD
Organizational Affiliation
Fondation Ophtalmologique Adolphe de Rothschild
Official's Role
Study Chair
Facility Information:
Facility Name
Fondation Ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of the Visual Information Change in Functional Dystonia
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