DYSCAR: Characterization of Dystonia

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00361465
First received: August 7, 2006
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

Dystonia is a rare disease leading to a severe handicap. It can be of primary or secondary origin. It is characterized by sustained muscle contractions, frequently causing twisting and repetitive movements or abnormal postures. These disorders are believed to be caused by some dysfunction of the basal ganglia (BG) circuitry, but the mechanisms are largely unknown.

A better understanding of the disorder requires significant improvements of its phenomenological description in relation to aetiology. We want to identify specific motor signatures of different forms of dystonia. To that aim, we will ask patients to perform movements of various complexities, while recording chronometric, kinematics and EMG data. The characteristics of the patients' movements will be compared to those of matched control subjects. We will examine abnormal co-activation in distal and proximal muscles to evaluate the characteristics of the loss of selectivity of the motor command in mobile vs. fixed dystonia. Consistency of the motor output patterns will be compared in three groups of patients. We will also study possible cognitive and limbic components of the disease, examining the influence of cognitive and emotional loads on movement production. Eventually we want to refine the criteria used to classify different forms of the disease, thus enabling clinicians to better predict the likely outcome of particular therapeutic procedures.


Condition Intervention
Dystonia
Parkinson Disease
Other: EMG and Kinematics recording

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Characterization of Dystonia and Influence of Cognitive-attentional Factors

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 75
Study Start Date: August 2006
Study Completion Date: December 2010
Groups/Cohorts Assigned Interventions
Parkinsonian patients presenting of the dystonia
15 Parkinsonian patients presenting of the dystonia of ONE or OFF at the time of the phases of driving fluctuations. These patients must present a dystonia of the upper limb, mainly localised than the level of the segment brachial or in distality.
Other: EMG and Kinematics recording

The experimental protocol envisages the recording of the movement and the bilateral recording of activity EMG during three types of tasks:

discrete driving tasks: movements of inflection and extension of the wrist car-generated, or produced in answer to an imperative stimulus try driving repetitive: sequence of inflection-extension of the wrist unilateral, bilateral in phase and bilateral in opposition of phase.

try driving complexes: movement of inflection and extension of the wrist with concurrent realization of a driving task controlatérale different, or of a cognitive task.

For the Parkinsonian patients, these various tests will be carried out twice: without antiparkinsonian treatment ("off") and under treatment ("one").

patients carrying a primary education dystonia affecting
15 patients carrying a primary education dystonia affecting at least one of the two upper limbs, without excessive involuntary movements
Other: EMG and Kinematics recording

The experimental protocol envisages the recording of the movement and the bilateral recording of activity EMG during three types of tasks:

discrete driving tasks: movements of inflection and extension of the wrist car-generated, or produced in answer to an imperative stimulus try driving repetitive: sequence of inflection-extension of the wrist unilateral, bilateral in phase and bilateral in opposition of phase.

try driving complexes: movement of inflection and extension of the wrist with concurrent realization of a driving task controlatérale different, or of a cognitive task.

For the Parkinsonian patients, these various tests will be carried out twice: without antiparkinsonian treatment ("off") and under treatment ("one").

patients carrying a secondary dystonia
15 patients carrying a secondary dystonia (consecutive with a perinatal suffering) affecting at least one of the two upper limbs, without excessive involuntary movements
Other: EMG and Kinematics recording

The experimental protocol envisages the recording of the movement and the bilateral recording of activity EMG during three types of tasks:

discrete driving tasks: movements of inflection and extension of the wrist car-generated, or produced in answer to an imperative stimulus try driving repetitive: sequence of inflection-extension of the wrist unilateral, bilateral in phase and bilateral in opposition of phase.

try driving complexes: movement of inflection and extension of the wrist with concurrent realization of a driving task controlatérale different, or of a cognitive task.

For the Parkinsonian patients, these various tests will be carried out twice: without antiparkinsonian treatment ("off") and under treatment ("one").

pilot subjects
30 healthy pilot subjects paired in sex, age (± 5 years), dominant laterality and level of schooling (15 subjects paired with the Parkinsonian patients and 15 subjects paired with the patients dystonic

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Parkinsonian patients, Dystonia patients,Major depression, Dementia, Acute psychosis, Clinical motor deficit making the movements impossible, joint or muscle pathology

Criteria

Inclusion Criteria:

  • Parkinsonian patients: idiopathic PD, aged 18 to 75 years, with medical insurance, presenting motor fluctuations with ON and OFF involuntary movements, able to sign informed consent, able to stay in a sitting position and perform the experimental tasks.
  • Dystonia patients: aged 18 to 75 years, with medical insurance, idiopathic or secondary dystonia affecting at least one of the upper limbs, able to sign informed consent, able to stay in a sitting position and perform the experimental tasks.

Exclusion Criteria:

  • Major depression, Dementia, Acute psychosis, Clinical motor deficit making the movements impossible, joint or muscle pathology.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00361465

Locations
France
Grenoble University Hospital
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Bettina DEBU, Professor University J Fourier, INSERM U 318
Principal Investigator: Pierre POLLAK, Professor University J Fourier, INSERM U318, Grenoble University Hospital
  More Information

No publications provided

Responsible Party: Pierre POLLAK-Professor, University Joseph Fourier, INSERM U318, Grenoble University Hospital
ClinicalTrials.gov Identifier: NCT00361465     History of Changes
Other Study ID Numbers: 0610
Study First Received: August 7, 2006
Last Updated: March 25, 2011
Health Authority: France: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Dyskinesias
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Parkinsonian Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014