Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of the Visual Information Change in Functional Dystonia (PRISMADYS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03270189
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.

Condition or disease Intervention/treatment Phase
Dystonia Dystonic Disorders Torticollis Movement Disorders Central Nervous System Diseases Nervous System Diseases Dyskinesias Neurologic Manifestations Device: prism glasses Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the Visual Information Change in Functional Dystonia
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arm Intervention/treatment
Experimental: orthoptic treatment
Patients with cervical dystonia occuring only during handwriting.
Device: prism glasses
orthoptic treatment by wearing prisms when writing

No Intervention: Controls
Patients without cervical dystonia.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270189


Contacts
Layout table for location contacts
Contact: Laurence Salomon, MD PhD +33148036454 lsalomon@for.paris
Contact: Sophie Sangla, MD +33148036890 ssangla@for.paris

Locations
Layout table for location information
France
Fondation Ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Sophie Sangla, MD       ssangla@for.paris   
Contact: Jean-Pierre BLOTON, PhD       jpbleton@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Layout table for investigator information
Study Chair: Jean-Pierre Bleton, PhD Fondation Ophtalmologique Adolphe de Rothschild

Layout table for additonal information
Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03270189     History of Changes
Other Study ID Numbers: SSA_2016_23
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Diseases
Central Nervous System Diseases
Disease
Dystonia
Dystonic Disorders
Dyskinesias
Movement Disorders
Torticollis
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms