NCT00361465

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

First QC Date

August 7, 2006

Last Update Submit

March 25, 2011

Conditions

Study Arms (4)

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

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

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

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

Interventions

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").

Parkinsonian patients presenting of the dystoniapatients carrying a primary education dystonia affectingpatients carrying a secondary dystonia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Major depression, Dementia, Acute psychosis, Clinical motor deficit making the movements impossible, joint or muscle pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

DystoniaParkinson Disease

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Bettina DEBU, Professor

    University J Fourier, INSERM U 318

    STUDY DIRECTOR
  • Pierre POLLAK, Professor

    University J Fourier, INSERM U318, Grenoble University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 8, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2010

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations