Effect of the Visual Information Change in Functional Dystonia

Nervous System Diseases Clinical Trial

— PRISMADYS  

Official title:

Effect of the Visual Information Change in Functional Dystonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03270189
• Other study ID #: SSA_2016_23
• Status: Terminated
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: September 19, 2022

Study information

• Verified date: February 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: September 19, 2022
• Est. primary completion date: December 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• prism glasses
orthoptic treatment by wearing prisms when writing

Locations

Country	Name	City	State
France	Fondation Ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of head movement occurring when writing	Difference of the angle measured with and without corrective prisms during the handwriting tasks	3 months