Effect of the Visual Information Change in Functional Dystonia

NCT03270189 | Terminated

• 1 other identifier: SSA_2016_23
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• measure of head movement occurring when writing

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

  3 months

Study Arms (2)

orthoptic treatment

EXPERIMENTAL

Patients with cervical dystonia occuring only during handwriting.

Device: prism glasses

Controls

NO INTERVENTION

Patients without cervical dystonia.

Interventions

prism glasses DEVICE

orthoptic treatment by wearing prisms when writing

orthoptic treatment

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Pierre Bleton, PhD

  Fondation Ophtalmologique Adolphe de Rothschild

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 1, 2017
• Study Start: September 18, 2017
• Primary Completion: December 19, 2021
• Study Completion: September 19, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

FR (1)