Study of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm
ERAMPPCI
1 other identifier
observational
55
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2011
Longer than P75 for all trials
1 active site
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 Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 5, 2016
December 1, 2016
5.3 years
June 23, 2016
December 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SRT
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
Day 0
Study Arms (4)
Parkinson best-On
two hours after taking two tablets of 125 mg dispersible Modopar®
Parkinson worst-off
after a drug withdrawal period ( morning fasting all dopaminergic treatment since the day before midnight)
Huntington
Control
Data collected from the existing database
Interventions
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre KRYSTKOWIAK, MD, PhD
CHU Amiens
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 27, 2016
Study Start
July 1, 2011
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 5, 2016
Record last verified: 2016-12