NCT03371407

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress83%
Jul 2019Oct 2027

First Submitted

Initial submission to the registry

May 31, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 4, 2019

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

8.2 years

First QC Date

May 31, 2017

Last Update Submit

January 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The electrophysiological (EEG) activity by the BioSemi 64 electrodes system

    Hertz identification of electrodes where signal fluctuations are the most important.

    6 months

Study Arms (3)

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

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

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

Interventions

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 participantsParkinsonian patient under dopaminergic medicationParkinsonian patient without dopaminergic medication

Eligibility Criteria

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

Patients suffering from Parkinson disease

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neurologie, Hôpital de la Timone, Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Alexandre EUSEBIO, MD, PHD

CONTACT

Camille DELANNOY

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

December 13, 2017

Study Start

July 4, 2019

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations