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

Parkinson Disease Clinical Trial

— ERAMPPCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814201
• Other study ID #: PI10-DR-DURU
• Status: Completed
• Phase: N/A
• First received: June 23, 2016
• Last updated: December 2, 2016
• Start date: July 2011
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Huntington Disease
• Parkinson Disease

Intervention

Behavioral:
• SRT
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No