Clinical trial NCT01249768: Parkinson's Disease, Diagnostic Observations (PADDO)
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Atypical Parkinsonism
Keywords: Prospective study
diagnostic accuracy
CSF
MRI
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a hypokinetic-rigid syndrome with a disease duration of maximum 36 months and in whom a definitive diagnosis has not been established yet.

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.


Eligibility criteria: 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

Primary outcomes:
measure: percentage of correct diagnosis for each of the specified ancillary investigations
timeFrame: 36 months
Secondary outcomes:
measure: Percentage of correct diagnosis for each of the specified ancillary investigations
timeFrame: 36 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: M Verbeek, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: B Bloem, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Rumund A, Aerts MB, Esselink RAJ, Meijer FJA, Verbeek MM, Bloem BR. Parkinson's Disease Diagnostic Observations (PADDO): study rationale and design of a prospective cohort study for early differentiation of parkinsonism. BMC Neurol. 2018 May 16;18(1):69. doi: 10.1186/s12883-018-1072-x.