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

February 11, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation ophtalmique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Study Chair: Jean-Pierre Bleton, PhD, Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2017

Primary Completion (ACTUAL)

December 19, 2021

Study Completion (ACTUAL)

September 19, 2022

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (ACTUAL)

September 1, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSA_2016_23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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