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Movement Error-processes and Sensorimotor Adaptation in Parkinsonian Patient (Kinarm)

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ClinicalTrials.gov Identifier: NCT03371407
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : August 13, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:
The aim of the present project is to document the relationship between the behavioral deficits and the electrophysiological anomalies observed in PD patients in tasks involving motor adaptation to visual or mechanical perturbations.

Condition or disease Intervention/treatment
Parkinson Disease Other: Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology

Detailed Description:

Parkinson Disease (PD) is a neurodegenerative pathology characterized by the death of dopaminergic neurons in of the substantia nigra pars compacta. The main clinical symptoms are akinesia-stiffness-tremor. These motor deficits are due to dysfunction in the network of the basal ganglia that constitute an ensemble of subcortical nuclei involved in movement control and motor learning. The implication of the basal ganglia (BG) in movement sequence learning (i.e. in movement selection processes) has been clearly established. However, their contribution to adaptation of movement execution remains uncertain. Until recently, the vast majority of the studies on motor adaptation have focused on one mechanism in particular: an implicit process through which motor performance is gradually improved on the basis of errors observed in movement execution, recruiting essentially cerebellar loops. Today, a new line of research has emerged seeking to identify different mechanisms contributing to motor adaptation. Specifically, the implication of cognitive strategies and reinforcement learning mechanisms has been the center of several recent studies, which thus have been emphasizing the role of the BG.

The aim of the present project is to document the relationship between the behavioral deficits and the electrophysiological anomalies observed in PD patients in tasks involving motor adaptation to visual or mechanical perturbations. Recent electrophysiological studies have revealed anomalies in the oscillatory activity in the BG-cortex loop in PD; namely the activity in the beta band (~20Hz) presents an excessive synchronization that might contribute to some behavioral symptoms. Interestingly, recent work has demonstrated that the synchronization in the BG and their cortical projections is 1) diminished by treatments such as dopaminergic medication (L-Dopa) or deep brain stimulation of the subthalamic nucleus (NST), and 2) modulated in relation to movement-error processes.

In this project,it is planned to to conduct two studies involving each several studies. The goal of the first study is twofold: first better understand the motor adaptation deficits specific to different stages of PD disease, and then investigate the influence of the dopaminergic medication on the latter. In this purpose, the behavioral performance and the electrophysiological (EEG) activity in PD patients will be examined during the early and more advanced stages of the pathology, on medication or not (ON or OFF L-Dopa). The specific interest of this study in the relationship between the beta-band activity and, on one side, potential deficits in the explicit cognitive strategies recruited in the initial phase of adaptation and, on the other side, anomalies in reinforcement learning mechanisms implicated in motor adaptation. A secondary goal will be to interpret the observations in light of neuroimaging data. The aim of the second study will be to explore oscillatory and synchronized activities in the BG-cortex loops during motor adaptation to visual or mechanical perturbations. The recording of NST LFP and EEG will implicated the participation of implanted PD patients.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Movement Error-processes and Sensorimotor Adaptation in Parkinsonian Patient
Actual Study Start Date : July 26, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Parkinsonian patient under dopaminergic medication Other: Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology
Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology, using an instrumentation, called the Kinarm, which assess objectively sensory, motor and cognitive functions
Parkinsonian patient without dopaminergic medication Other: Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology
Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology, using an instrumentation, called the Kinarm, which assess objectively sensory, motor and cognitive functions
Control participants Other: Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology
Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology, using an instrumentation, called the Kinarm, which assess objectively sensory, motor and cognitive functions


Outcome Measures
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Primary Outcome Measures :
  1. The electrophysiological (EEG) activity by the BioSemi 64 electrodes system [ Time Frame: 6 months ]
    Hertz identification of electrodes where signal fluctuations are the most important.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from Parkinson disease
Criteria

Inclusion Criteria:

  • Patient aged over 18 years
  • Right-handed patients , following the Modified Edinburgh Handedness Inventory
  • Patient with Parkinson's disease according to Gibb criteria
  • Idiopathic Parkinson's Disease with a history of more than 5 years
  • Stimulation electrodes implanted in the 2 subthalamic nuclei in the Functional and Stereotactic Neurosurgery Department of La Timone Hospital (Pr REGIS).
  • Dopa-sensitivity greater than 50%
  • Absence of signs of cognitive impairment
  • Patient who agreed to participate in the study and signed informed consent
  • Patient affiliated with a health insurance

Exclusion Criteria:

  • Person not likely to participate in the entire study
  • Pregnant or likely to be pregnant during the year
  • Patients unable to give their informed consent (detainees, adults under guardianship)
  • Person unable to understand the nature and purpose of the study, or presneting with understanding difficulties which could compromise the proper conduct of the study
  • Person refusing to sign the Informed Consent Form
  • A person who is able to give his or her consent but unable to read / write French language
  • patient who can not participate in an MRI study according to the criteria listed in the attached form.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371407


Contacts
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Contact: Alexandre EUSEBIO, MD, PHD +33491384333 alexandre.eusebio@ap-hm.fr
Contact: Camille DELANNOY

Locations
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France
Service de Neurologie, Hôpital de la Timone, Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Alexandre Eusebio, MD, PhD    +33491384333    alexandre.eusebio@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03371407    
Other Study ID Numbers: 2016-36
2016-A01196-45 ( Other Identifier: ANSM )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases