NCT02428816

Brief Summary

Based on previous promising results, the next step for the validation of a multimodal MRI method in diagnosis and follow up of patients reached by parkinsonian syndromes is (i) to test whether the multimodal neuroimaging is able to discriminate at the individual level, patients with multiple system atrophy parkinsonism (MSA) and patients with idiopathic Parkinson's disease (PD) (ii) to determine whether the method is sensitive to measure changes over time for the two diseases, according to imaging, neuropsychological and other clinical data. Patients will be compared with healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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 24, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2016

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

3.5 years

First QC Date

January 28, 2013

Last Update Submit

February 4, 2021

Conditions

Parkinson's DiseaseMultiple System Atrophy

Keywords

differential diagnosismultimodal MRIParkinson's DiseaseMultiple System Atrophy

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure to discriminate individual patients and patients with MPI and AMS through multimodal MRI isolating multiparametric spatial signature resulting from a combination of markers in multimodal imaging.

    1 year

Secondary Outcomes (1)

  • correlate MP and MSA disease severity with extracted multimodal MRI biomarkers in whole brain

    1 year

Study Arms (3)

Patients with Parkinson's Disease

EXPERIMENTAL

Patients with PD will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)

Other: MRI acquisitionBehavioral: behavioral evaluations

Patients with MSA

EXPERIMENTAL

Patients with MSA will be submitted to an MRI acquisition and to behavioural evaluations in each visits (two visits planned)

Other: MRI acquisitionBehavioral: behavioral evaluations

Controls

EXPERIMENTAL

30 healthy controls will be submitted to an MRI acquisition and to behavioural evaluations in a sole visit

Other: MRI acquisitionBehavioral: behavioral evaluations

Interventions

MRI acquisitionOTHER

MRI acquisitions

ControlsPatients with MSAPatients with Parkinson's Disease
behavioral evaluationsBEHAVIORAL

Evaluations about motor abilities, sleep, cognition and lifestyle

ControlsPatients with MSAPatients with Parkinson's Disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent signed
  • right handed patients
  • Mini Mental Score \> 22
  • no other neurological disease than Parkinson's Disease (PD) or Multiple System Atrophy (MSA)
  • non-demented patients reached by PD or MSA (according to diagnosis criteria from UK PD Brain Bank and from Gilman and colleagues, 1998, for PD and MSA respectively)
  • for PD patients only : Hoehn and Yahr score from 2 to 3

You may not qualify if:

  • claustrophobia
  • contraindications to MRI (cardiac or auditive prothesis, pacemakers, cerebral clip, stimulating electrodes)
  • pregnant women
  • major neuropsychiatric disease
  • refusal to be informed in case of cerebral anomaly detected during MRI acquisition
  • uncompensated thyroid deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inserm Umr 825

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson DiseaseMultiple System Atrophy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Olivier Rascol, Pr

    INSERM UMR 825, France

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 28, 2013

First Posted

April 29, 2015

Study Start

January 24, 2013

Primary Completion

July 28, 2016

Study Completion

July 28, 2016

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

FR(1)