Parkinson's Disease, Diagnostic Observations (PADDO)

Observational Study Assessing the Diagnostic Contribution of 3-Tesla MRI, CSF Analysis and a Second Opinion in a Specialized Movement Disorder Centre, in Differentiating Between Parkinson's Disease and Atypical Parkinsonism

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01249768

Acronym

PADDO

Enrollment

150

Registered

2010-11-30

Start date

2010-07-31

Completion date

2018-07-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Parkinsonism, Parkinson's Disease

Keywords

Prospective study, diagnostic accuracy, CSF, MRI

Brief summary

Background: Parkinson's Disease and the Atypical Parkinsonian Disorder (like Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia) are disease entities with partly common symptomatology. Especially very early in the course of disease, the differentiation between both disease entities can be challenging, even for specialists in the field of movement disorder. However, the establishment of a correct diagnosis is very important for adequate patientcounseling, treatment and the correct inclusion of patients in research trials. Ancillary diagnostic investigations are looked upon to aid in this diagnostic dilemma. Objective: To investigate the value of ancillary diagnostic investigations, more specific MRI, analysis of cerebrospinal fluids and a second opinion in a specialized movement disorder centre, to differentiate Parkinson's disease and the Atypical Parkisonisonian disorder.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hypokinetic rigid syndrome * Disease duration of maximum 36 months

Exclusion criteria

* Probable diagnosis of PD without any red flags * Probable diagnosis MSA * Probable diagnosis PSP * Diagnosis CBD * Diagnosis DLB * Probable diagnosis Vascular Parkinsonism * Other neurodegenerative disease than parkinsonism * A prior history of brain surgery * Instable comorbidity

Design outcomes

Primary

Measure	Time frame	Description
percentage of correct diagnosis for each of the specified ancillary investigations	36 months	Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism

Secondary

Measure	Time frame	Description
Percentage of correct diagnosis for each of the specified ancillary investigations	36 months	Percentage of correct diagnosis for each of the specified ancillary investigations(MRI, CSF analysis, and second opinion) to differentiate between the specific diagnosis (PD, MSA, PSP, CBD, LBD, VaP)

Countries

Netherlands

Contacts

Primary ContactB Bloem, Prof, MD

b.bloem@neuro.umcn.nl

Outcome results