Evaluation of Behaviour in Parkinson's Disease. Normal Values in Healthy Subjects (ECMP)

June 28, 2016 updated by: University Hospital, Grenoble

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy participants without any neurologic disease
  • Men and women from 25 to 75 years old
  • French mother tong
  • without cognitive troubles (MMS ≥ 24)

Exclusion Criteria:

  • Subject under legal guardianship
  • Pregnant woman or with childbearing potential without contraceptive device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy participants
Submission of the scale 'Evaluation of behaviour in Parkinson's Disease' to healthy subjects
Other: Healthy participants
Semi-structured interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ECMP score
Time Frame: 3 hours
Semi-structured interview
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Anna Castrioto, MD, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 28, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2009-A00103-54/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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