Parkinson DiseaseERAMPPCINCT02814201
Study of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm
An observational study of Parkinson Disease and Huntington Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Huntington Disease
- What is being tested?
- SRT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson Disease, Huntington Disease
- Being tested
- SRT
- Keywords
- Motor slowing, Computerized mental chronometry paradigm
- Medical subject headings
- Parkinson Disease, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRTBehavioural
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
| Study group | Role | What they receive |
|---|---|---|
| Parkinson best-On | two hours after taking two tablets of 125 mg dispersible Modopar® Receives: Behavioral: SRT | |
| Parkinson worst-off | after a drug withdrawal period ( morning fasting all dopaminergic treatment since the day before midnight) Receives: Behavioral: SRT | |
| Huntington | Not described Receives: Behavioral: SRT | |
| Control | Data collected from the existing database Receives: Behavioral: SRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRT
simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient )
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJul 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre KRYSTKOWIAK, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814201
- Sponsor's protocol ID
- PI10-DR-DURU
- Acronym
- ERAMPPCI
- Status last verified
- Dec 2016
- First submitted
- 23 Jun 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Motor Slowing in Parkinson's Disease by a Computerized Mental Chronometry Paradigm
- ClinicalTrials.gov ID
- NCT02814201
- Acronym / sponsor ID
- ERAMPPCI / PI10-DR-DURU
- Conditions
- Parkinson Disease, Huntington Disease
- Keywords
- Motor slowing, Computerized mental chronometry paradigm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parkinson best-On | – | Behavioral: SRTtwo hours after taking two tablets of 125 mg dispersible Modopar® |
| Parkinson worst-off | – | Behavioral: SRTafter a drug withdrawal period ( morning fasting all dopaminergic treatment since the day before midnight) |
| Huntington | – | Behavioral: SRT |
| Control | – | Behavioral: SRTData collected from the existing database |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- Agreeing to participate in the study
- French mother tongue
- MMSE > 20/30
- Specific to the MP and MH:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRTsimple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase "worst -off" at the Parkinson's patient ) | Behavioural | Control, Huntington, Parkinson best-On, Parkinson worst-off |
Primary outcome
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 )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre KRYSTKOWIAK, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Huntington Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRT (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.