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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.

Primary conditionTorticollisRegistry: DystoniaReclassifiedWhy we changed it
Registry
Dystonia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Torticollis
Why
  1. The study's listed conditions name Torticollis, a narrower term within Dystonia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

In context

Torticollis Reclassified

121 studies on the registry are indexed under Torticollis; 18 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 76 interventional studies indexed under Torticollis.

Browse Torticollis studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Browse Fondation Ophtalmologique Adolphe de Rothschild studies →

Compared within Torticollis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dystonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • Fondation Ophtalmique Adolphe de Rothschild
    Paris, 75019, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Dec 2021, 51 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2017
First posted
Sep 1, 2017
StartActual
Sep 18, 2017
Primary completionActual
Dec 19, 2021
CompletionActual
Sep 19, 2022
Last update
Feb 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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Discussion

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