Abnormal Movements, Cerebellum and Sensorimotor : Oculomotor Study

NCT01495897 | Completed

• 2 other identifiers: C10-182010-A00740-39
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Dystonia; Parkinson Disease

Keywords

Dystonia; Cerebellar; ocular movements; DYT 11; sensorimotor integration

Outcome Measures

Primary Outcomes (2)

• Saccadic adaptation

  Saccadic adaptation, evaluated as the percentage of changes in the mean saccade amplitude between the pre-test and post-test.

  between the pre-test and post-test, maximum 4 hours

• Characteristics of the saccade

  latency, velocity, duration of the saccade

  measured during the analysis of the recorded session, maximum 4 hours

Study Arms (4)

Healthy

OTHER

Healthy volunteers

Device: Tracking eye movement

Dystonia

EXPERIMENTAL

patients with Primary Dystonia

Device: Tracking eye movement

Parkinson

EXPERIMENTAL

patients with Parkinson's disease

Device: Tracking eye movement

Essential tremor

EXPERIMENTAL

patients with essential tremor with or without deep brain stimulation

Device: Tracking eye movement; Device: Tracking eye movement under deep brain stimulation

Interventions

Tracking eye movement DEVICE

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.

Dystonia; Essential tremor; Healthy; Parkinson

Tracking eye movement under deep brain stimulation DEVICE

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.

Essential tremor

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

: Fédération des Maladies du Système Nerveux

Paris, 75013, France

Location

Related Publications (1)

• Hubsch C, Vidailhet M, Rivaud-Pechoux S, Pouget P, Brochard V, Degos B, Pelisson D, Golmard JL, Gaymard B, Roze E. Impaired saccadic adaptation in DYT11 dystonia. J Neurol Neurosurg Psychiatry. 2011 Oct;82(10):1103-6. doi: 10.1136/jnnp.2010.232793. Epub 2011 Mar 8.

  PMID: 21386109 BACKGROUND

MeSH Terms

Conditions

Dystonia; Parkinson Disease

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Emmanuel Flamand-Roze, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: December 20, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: September 4, 2025

Record last verified: 2016-02

Locations

FR (1)