Study of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm (ERAMPPCI)

December 2, 2016 updated by: Centre Hospitalier Universitaire, Amiens
Action slowing has been demonstrated in many diseases. Parkinson's disease (PD) and Huntington's disease (HD) are two neurodegenerative diseases affecting the basal ganglia, particularly the medial globus pallidus, and the clinical expression of these two diseases is characterized by a combination of motor and cognitive disorders, but with two opposing patterns of dysfunction. Action slowing has been demonstrated in both of these diseases and has been extensively studied in Parkinson's disease, suggesting a perceptive-cognitive origin. Far fewer studies have been conducted in Huntington's disease. However, all of these studies were performed with different methodologies in small cohorts and the value of the proposed study is to use a validated and standardized computerized mental chronometry paradigm, providing a better understanding of the mechanisms of action slowing in these two diseases and to more clearly define a disease-specific profile.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Hoehn and Yahr stage 1 to 3 Parkinson's disease and patients with Shoulson stage I and II Huntington's disease, in whom admission to the Neurology ward is scheduled in the context of their follow-up, comprising a neuropsychological assessment (together with an acute L-dopa administration test for Parkinsonian patients) will be included

Description

Inclusion Criteria:

  • Agreeing to participate in the study
  • French mother tongue
  • MMSE > 20/30
  • Specific to the MP and MH:

    • Parkinson's disease:

      • defined by the criteria of the UKPDSBB
      • stage 1 , 2 or 3 Hoehn and Yahr (ON)
      • age of onset of the disease known
      • brain MRI performed during follow-up
    • Huntington disease :

      • genetically defined (CAG > 35)
      • weaning neuroleptic ( Tercian® and Solian® : 2 days; Haldol® : 5 days ; Tiapridal® and Xenazine : 1 day ; Zyprexa® : 4 days)
      • Early stage : Fahn and Shoulson I and II is a CFT score between 7 and 13

Exclusion Criteria:

  • Illiteracy, writing or reading difficulties
  • Visual perceptual auditory deficit or preventing reading, drawing, writing or understanding instructions
  • Visual hallucinations
  • Significant history may sound on cognition (unbalanced thyroid dysfunction, ischemic heart disease or embolic unstabilized or symptomatic, progressive neoplasia, chronic alcoholism weaned or not)
  • Current or previous neurological diseases other than MH or MP: ischemic cerebral vascular accident or bleeding, head injuries (loss of higher knowledge in 15 minutes), epilepsy requiring treatment.
  • Psychiatric disorders depression unless treated (stable treatment for 1 month)
  • Psychotropic treatment (except anxiolytic, antidepressant steady since 1 month)
  • Inability to achieve an autonomous operation without technical assistance over a distance of 20 meters.
  • Inability to stand without technical assistance for 30 seconds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson best-On
two hours after taking two tablets of 125 mg dispersible Modopar®
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
Parkinson worst-off
after a drug withdrawal period ( morning fasting all dopaminergic treatment since the day before midnight)
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
Huntington
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
Control
Data collected from the existing database
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SRT
Time Frame: Day 0
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre KRYSTKOWIAK, MD, PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (ESTIMATE)

June 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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