- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02814201
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
Conditions
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
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Dementia
- Cognition Disorders
- Chorea
- Parkinson Disease
- Huntington Disease
Other Study ID Numbers
- PI10-DR-DURU
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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