NCT02445469

Brief Summary

Parkinsonian syndrome is clinically characterized by the presence of resting tremor, rigidity, bradykinesia and postural instability. Parkinsonian disorders include Parkinson's disease (PD), progressive supranuclear palsy (PSP), corticobasal dementia (CBD), multiple system atrophy (MSA) and vascular parkinsonism (VP). Each of these diseases has a singular physiopathological origin, course and prognosis. Numerous imaging studies consequently aimed at finding markers to early make the distinction between the different types of parkinsonism, in order to identify patients who could benefit from dopaminergic agonist therapy. Excessive iron deposition in the subcortical and brainstem nuclei has been described in numerous neurodegenerative disorders including Parkinson's disease. Increased iron levels are more frequent in area that are rich in dopaminergic neurons and have been implicated in the development of movement disorders, the distribution of areas with increased iron deposition however varying according to parkinsonism types. Iron deposition quantification could thus potentially help in differentiating parkinsonism types and could improve therapy guidance. Quantitative susceptibility mapping (QSM) locally estimates the magnetic susceptibility of brain tissues based on gradient-echo signal phase. The local susceptibility being sensitive to the presence of paramagnetic susbtances, QSM allows the non-invasive evaluation of iron distribution and quantification in the brain with high image quality (Liu et al., 2013). However, since iron deposition followed an exponential curve during normal aging in most of the basal ganglia the potential of QSM to distinguish between healthy and parkinsonian subjects in elderly remains unclear. The aim of this study was thus to determine susceptibility values in the basal ganglia of elderly patients with parkinsonian syndromes, to compare these values to healthy aged-matched controls and between parkinsonian syndrome types. Secondly, investigators aimed to evaluate microstructural changes in the basal ganglia using diffusion tensor imaging (DTI) in the same population and to determine whether susceptibility and DTI parameter changes are correlated. Finally investigators sought to assess the relation between susceptibility/DTI parameter values in the basal ganglia and behavioral measures of motor and cognitive abilities.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

4 years

First QC Date

May 7, 2015

Last Update Submit

March 30, 2017

Conditions

Parkinson's DiseaseMultiple System AtrophyProgressive Supranuclear PalsyVascular Parkinsonism

Outcome Measures

Primary Outcomes (1)

  • Quantitative susceptibility mapping

    Susceptibility weighted imaging raw data are preprocessed to obtain magnitude and phase images for each echo time. Quantitative susceptibility maps are then generated using a in-house software.

    1 month

Secondary Outcomes (1)

  • Diffusion tensor imaging

    1 month

Study Arms (5)

Parkinson's disease

OTHER

MRI exam of the brain

Other: MRI exam of the brain

Multiple System Atrophy

OTHER

MRI exam of the brain

Other: MRI exam of the brain

Progressive Supranuclear Palsy

OTHER

MRI exam of the brain

Other: MRI exam of the brain

Vascular parkinsonism

OTHER

MRI exam of the brain

Other: MRI exam of the brain

Healthy volunteers

OTHER

MRI exam of the brain

Other: MRI exam of the brain

Interventions

MRI exam of the brainOTHER

MRI exam of the brain

Healthy volunteersMultiple System AtrophyParkinson's diseaseProgressive Supranuclear PalsyVascular parkinsonism

Eligibility Criteria

Age70 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • For Both patients and healthy volunteers :
  • Age limits ≥ 70 et ≤ 90 years
  • Subject able to understand the nature, the aim and the methodology of the study.
  • Collection of the infomed consent
  • Affiliation or recipient with the mode of social security.
  • For the patients :
  • Parkinsonian Syndrome began after 65 years defined as Parkinson's disease Multiple System Atrophy (AMS), Progressive Supranuclear Palsy, Vascular Parkinson
  • For the healthy volunteers :
  • The healthy volunteers will be selected according to the age and the of the study's patients.

You may not qualify if:

  • For Both patients and healthy volunteers :
  • Person with majority age protected by the law (supervision or trusteeship).
  • Loss of liberty per court order or administative
  • Subject presenting contraindications in MRI (valve of ventricular diversion, Ferromagnetic foreign bodies, pace-maker, Implantable defibrillator (ICD), Cochlear hearing implant, Claustrophobia, ….)
  • Antecedent of serious cranial trauma (according to classification) of ischeamic stroke ou intracranial hematoma.
  • For the patients :
  • Patient treated by neuroleptics
  • For the healthy volunteers :
  • Antecedent of neurological desease
  • Antecedent of psychiatric trouble de trouble psychiatrique (Except anxio-depressive disorder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Neuroradiologie, Hopital Gui de Chauliac, CHU de Montpellier

Montpellier, France, 34295, France

Location

MeSH Terms

Conditions

Parkinson DiseaseMultiple System AtrophySupranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas Menjot de Champfleur, Medical PHD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 15, 2015

Study Start

December 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

FR(1)