NCT02814201

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

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

5.3 years

First QC Date

June 23, 2016

Last Update Submit

December 2, 2016

Conditions

Keywords

Motor slowingComputerized mental chronometry paradigm

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®

Behavioral: SRT

Parkinson worst-off

after a drug withdrawal period ( morning fasting all dopaminergic treatment since the day before midnight)

Behavioral: SRT

Huntington

Behavioral: SRT

Control

Data collected from the existing database

Behavioral: SRT

Interventions

SRTBEHAVIORAL

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

ControlHuntingtonParkinson best-OnParkinson worst-off

Eligibility Criteria

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

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

Location

MeSH Terms

Conditions

Parkinson DiseaseHuntington Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDementiaChoreaDyskinesiasHeredodegenerative Disorders, Nervous SystemGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Pierre KRYSTKOWIAK, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

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

Locations