PRISMADYS: Effect of the Visual Information Change in Functional Dystonia

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT03270189

Collaborator

(none)

Enrollment

Location

Arms

99.4

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 18, 2017

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

measure of head movement occurring when writing [3 months]
Difference of the angle measured with and without corrective prisms during the handwriting tasks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 71 Years

Sexes Eligible for Study:

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:

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