Effect of the Visual Information Change in Functional Dystonia

NCT ID: NCT03270189

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-18

Study Completion Date

2022-09-19

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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orthoptic treatment

Patients with cervical dystonia occuring only during handwriting.

Group Type EXPERIMENTAL

prism glasses

Intervention Type DEVICE

orthoptic treatment by wearing prisms when writing

Controls

Patients without cervical dystonia.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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prism glasses

orthoptic treatment by wearing prisms when writing

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Pierre Bleton, PhD

Role: STUDY_CHAIR

Fondation Ophtalmologique Adolphe de Rothschild

Locations

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Fondation Ophtalmique Adolphe de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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SSA_2016_23

Identifier Type: -

Identifier Source: org_study_id

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