NCT02820428

Brief 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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

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

April 1, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
Last Updated

July 1, 2016

Status Verified

May 1, 2016

Enrollment Period

6 years

First QC Date

May 25, 2016

Last Update Submit

June 28, 2016

Conditions

Behaviour

Outcome Measures

Primary Outcomes (1)

  • ECMP score

    Semi-structured interview

    3 hours

Study Arms (1)

Healthy participants

OTHER

Submission of the scale 'Evaluation of behaviour in Parkinson's Disease' to healthy subjects

Other: Healthy participants

Interventions

Healthy participantsOTHER

Semi-structured interview

Healthy participants

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior

Study Officials

  • Anna Castrioto, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

July 1, 2016

Study Start

April 1, 2009

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 1, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share