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TerminatedNCT03270189PRISMADYSUpdated Feb 14, 2023

Effect of the Visual Information Change in Functional Dystonia

An interventional study of prism glasses in Dystonia, Dystonic Disorders and Torticollis, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Terminated at 1 site in France. Open to participants aged 18 Years to 71 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Treatment

Why this study was terminated
lack of recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 71 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dystonia
  • Dystonic Disorders
  • Torticollis
  • Movement Disorders
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Dyskinesias
  • Neurologic Manifestations
03

Who can participate

Ages eligible
18 Years to 71 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    orthoptic treatment

    Patients with cervical dystonia occuring only during handwriting.

    Device: prism glasses

  • No intervention
    Controls

    Patients without cervical dystonia.

Interventions

  • Deviceprism glasses

    orthoptic treatment by wearing prisms when writing

05

What researchers measure

Primary outcomes

  1. measure of head movement occurring when writing

    Difference of the angle measured with and without corrective prisms during the handwriting tasks

    Time frame: 3 months

06

Study locations

1 site
  • Fondation Ophtalmique Adolphe de Rothschild
    Paris, 75019, France
07

Registry details

Key details

Study ID
NCT03270189
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Sep 18, 2017
Primary completion
Dec 19, 2021
Completion
Sep 19, 2022
Last update
Feb 14, 2023

Study contacts

Jean-Pierre Bleton, PhD
study chair · Fondation Ophtalmologique Adolphe de Rothschild

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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