BehaviourECMPNCT02820428
Evaluation of Behaviour in Parkinson's Disease. Normal Values in Healthy Subjects
A study testing Healthy participants in people with Behaviour, run by University Hospital, Grenoble.
Trial summary
Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment and must be considered in treatment policies. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behaviour
- What is being tested?
- Healthy participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2015
- Phase
- Interventional
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants without any neurologic disease
- Men and women from 25 to 75 years old
- French mother tong
- without cognitive troubles (MMS ≥ 24)
Who cannot join
- Subject under legal guardianship
- Pregnant woman or with childbearing potential without contraceptive device
About this study
Official title: Evaluation Comportementale Dans la Maladie de Parkinson. Normes Chez Des Sujets Sains
Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment and must be considered in treatment policies.
Due to their specificity and the absence of an appropriate evaluation tool, behavioral disorders are rarely searched for.
Therefore, investigators developed a scale permitting qualitative and quantitative evaluation of behavior according to the severity of the disorders.
This study aims to define reference values for healthy individuals
Read the detailed description
The application of the scale includes a semi-structured interview
The ECMP scale consists of 21 items, each of which may be assessed by use of a 5 point scale (not at all - light trouble - moderate trouble - important trouble - severe trouble)
- Conditions
- Behaviour
- Being tested
- Healthy participants
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy participantsOther
Semi-structured interview
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Other | Submission of the scale 'Evaluation of behaviour in Parkinson's Disease' to healthy subjects Receives: Other: Healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECMP score
Semi-structured interview
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startApr 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BehaviourStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Castrioto, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820428
- Sponsor's protocol ID
- 2009-A00103-54/3
- Acronym
- ECMP
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Comportementale Dans la Maladie de Parkinson. Normes Chez Des Sujets Sains
- ClinicalTrials.gov ID
- NCT02820428
- Acronym / sponsor ID
- ECMP / 2009-A00103-54/3
- Conditions
- Behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Jul 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.
Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment and must be considered in treatment policies.
Due to their specificity and the absence of an appropriate evaluation tool, behavioral disorders are rarely searched for.
Therefore, investigators developed a scale permitting qualitative and quantitative evaluation of behavior according to the severity of the disorders.
This study aims to define reference values for healthy individuals
Detailed description
The application of the scale includes a semi-structured interview
The ECMP scale consists of 21 items, each of which may be assessed by use of a 5 point scale (not at all - light trouble - moderate trouble - important trouble - severe trouble)
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Other | Other: Healthy participantsSubmission of the scale 'Evaluation of behaviour in Parkinson's Disease' to healthy subjects |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy participants without any neurologic disease
- Men and women from 25 to 75 years old
- French mother tong
- without cognitive troubles (MMS ≥ 24)
Key exclusion criteria (2 listed)
- Subject under legal guardianship
- Pregnant woman or with childbearing potential without contraceptive device
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 |
|---|---|---|
| Healthy participantsSemi-structured interview | Other | Healthy participants |
Primary outcome
ECMP score
Time frame: 3 hours
Semi-structured interview
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 1 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Anna Castrioto, MD principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing Healthy participants in people with Behaviour, run by University Hospital, Grenoble.
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 4 inclusion and 2 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 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
ECMP score (time frame: 3 hours). 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 1 Jul 2016.