NCT01792843

Brief Summary

  • a data driven approach has identified different cognitive phenotypes in Parkinson's disease (PD)
  • this heterogeneity possibly reflects the diversity of the neuronal damage caused by the disease
  • we hypothesize that the different clinical presentations are associated to specific anatomical and functional correlates

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

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

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 2, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

February 13, 2013

Last Update Submit

February 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency (%) of the cognitive profile

    Frequency of the different observed cognitive profile, as coming from the cluster analysis

    2 years

Secondary Outcomes (1)

  • Grey matter density (voxels)

    2 years

Other Outcomes (1)

  • EEG power (microvolts2)

    2 years

Study Arms (1)

Parkinson's disease

Patients with Parkinson's disease according to international criteria

Behavioral: data

Interventions

dataBEHAVIORAL

* comparisons of clinical characteristics * comparisons of cognitive profiles * comparisons of grey matter density patterns * comparisons of EEG rhythms features

Parkinson's disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease, according to international criteria, irrespective of their disease stage or their current antiparkinsonian medication

You may qualify if:

  • Males or females;
  • to 80 years;
  • Parkinson's disease, according to international criteria;
  • Without neurological co-morbidity;
  • Benefiting from health insurance;
  • Having read and understood the information form and having signed the consent form.

You may not qualify if:

  • Pregnant or breastfeeding women;
  • Parkinsonian syndrome other than PD;
  • Currently participating in an other clinical trial or study;
  • Patient whose physical or mental condition is incompatible with the study assessments;
  • Person under tutorship or curatorship;
  • Subjects with claustrophobia
  • Subjects carrying incompatible metallic devices such as pacemakers and certain mechanical valves
  • PD patients treated by deep brain stimulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Related Publications (1)

  • Carey G, Lopes R, Viard R, Betrouni N, Kuchcinski G, Devignes Q, Defebvre L, Leentjens AFG, Dujardin K. Anxiety in Parkinson's disease is associated with changes in the brain fear circuit. Parkinsonism Relat Disord. 2020 Nov;80:89-97. doi: 10.1016/j.parkreldis.2020.09.020. Epub 2020 Sep 19.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Kathy Dujardin, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

February 2, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations