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

Behaviour Clinical Trial

— ECMP  

Official title:

Evaluation Comportementale Dans la Maladie de Parkinson. Normes Chez Des Sujets Sains

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820428
• Other study ID #: 2009-A00103-54/3
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: June 28, 2016
• Start date: April 2009
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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.

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Behaviour

Intervention

Other:
• Healthy participants
Semi-structured interview

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECMP score	Semi-structured interview	3 hours	No