Parkinson's Disease, Diagnostic Observations (PADDO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01249768
First received: November 26, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition
Parkinson's Disease
Atypical Parkinsonism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • percentage of correct diagnosis for each of the specified ancillary investigations [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Percentage of correct diagnosis for each of the specified ancillary investigations to differentiate between either PD or atypical parkinsonism


Secondary Outcome Measures:
  • Percentage of correct diagnosis for each of the specified ancillary investigations [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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)


Biospecimen Retention:   Samples With DNA

Whole blood, cerebrospinal fluids


Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort
The cohort will consist of 150 patients with a hypokinetic rigid syndrome and a disease duration of maximum 36 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249768

Locations
Netherlands
Radboud University Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: M Verbeek, PhD, MSc Radboud University
Principal Investigator: B Bloem, Prof, MD Radboud University
  More Information

No publications provided

Responsible Party: mr L. Lubbers, Radboud University
ClinicalTrials.gov Identifier: NCT01249768     History of Changes
Other Study ID Numbers: PADDO
Study First Received: November 26, 2010
Last Updated: November 26, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Prospective study
diagnostic accuracy
CSF
MRI

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 10, 2014