Trial record 3 of 3 for:    "myoclonus-dystonia"

Abnormal Movements, Cerebellum and Sensorimotor : Oculomotor Study (MOUVADOC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01495897
First received: May 18, 2011
Last updated: December 16, 2011
Last verified: December 2011
  Purpose

Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested.

The investigators propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.

Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between pre-test and post-test.

Expected results:

  • no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
  • abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.

Condition Intervention
Healthy
Dystonia
Parkinson Disease
Device: Tracking eye movement
Device: Tracking eye movement under deep brain stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Adaptation Sensorimotrice, Cervelet et Mouvements Anormaux: Projet d'étude Oculomotrice

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Saccadic adaptation [ Time Frame: between the pre-test and post-test, maximum 4 hours ] [ Designated as safety issue: No ]
    Saccadic adaptation, evaluated as the percentage of changes in the mean saccade amplitude between the pre-test and post-test.

  • Characteristics of the saccade [ Time Frame: measured during the analysis of the recorded session, maximum 4 hours ] [ Designated as safety issue: No ]
    latency, velocity, duration of the saccade


Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy
Healthy volunteers
Device: Tracking eye movement
Device: studying Saccadic eye movements with a video eye tracker: The subjects are seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location.
Experimental: Dystonia
patients with Primary Dystonia
Device: Tracking eye movement
Device: studying Saccadic eye movements with a video eye tracker: The subjects are seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location.
Experimental: Parkinson
patients with Parkinson's disease
Device: Tracking eye movement
Device: studying Saccadic eye movements with a video eye tracker: The subjects are seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location.
Experimental: Essential tremor
patients with essential tremor with or without deep brain stimulation
Device: Tracking eye movement
Device: studying Saccadic eye movements with a video eye tracker: The subjects are seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location.
Device: Tracking eye movement under deep brain stimulation
Device: studying Saccadic eye movements with a video eye tracker. If the patient has deep brain stimulation, recording will be made in the morning, before the usual morning start of the deep brain stimulation.

Detailed Description:

Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. High frequency stimulation of the ventral intermedius nucleus (Vim) of the thalamus, relay for the cerebellar output, is successfully used for the treatment of severe essential tremor. It occasionally induces adverse event such as balance disorders or cerebellar symptoms. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested. It seems that dystonia and essential tremor could be the result of basal ganglia or cerebellar dysfunction, or from dysfunction of structures controlled at the same time by the cerebellum and the basal ganglia.

methodology: We propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.

A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.

The subjects will be seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location. This avoided any post-saccadic visual feedback that would counteract the adaptive mechanism. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between the pre-test and post-test.

Expected results:

  • no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
  • abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Age ≥18 years
  • -normal cognitive functions (>24y)
  • Normal clinical examination of ocular mobility, visualization of the target
  • No drug potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug, antiepileptic.
  • Dystonia or essential tremor or Parkinson: diagnostic made by a neurologist
  • For DYT11: mutation in SGCE gene.
  • For dystonia: No secondary dystonia
  • For Parkinson : UPDRS<28
  • No other neurological disorder

For the patient having deep brain stimulation:

  • Duration of stimulation> 6 months
  • Cerebral imagery post operation made
  • Stimulation parameter stable since 3 months at least.
  • Usual stop of the stimulation during the night

Exclusion criteria:

  • Uncontrollable medical problems not related to M-D
  • Current active psychiatric disorder
  • Intake during the last 3 days of drugs potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug
  • Subjects legally protected.
  • Subjects who are not enrolled at social security.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495897

Contacts
Contact: Emmanuel Flamand-Roze, MD, PhD +331 42 16 57 78 emmanuel.flamand-roze@psl.aphp.fr

Locations
France
: Fédération des Maladies du Système Nerveux Recruiting
Paris, France, 75013
Contact: Emmanuel Flamand-Roze, MD, PhD    +331 42 16 57 78    emmanuel.flamand-roze@psl.aphp.fr   
Principal Investigator: Emmanuel Flamand-Roze, MD, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Emmanuel Flamand-Roze, MD, PhD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01495897     History of Changes
Other Study ID Numbers: C10-18, 2010-A00740-39
Study First Received: May 18, 2011
Last Updated: December 16, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Dystonia
Cerebellar
ocular movements
DYT 11
sensorimotor integration

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

ClinicalTrials.gov processed this record on September 18, 2014