NCT00368199

Brief Summary

The purpose of the study is to determine the sensitivity and specificity of transcranial duplex scanning (TCD) and single photon emission computer tomography (SPECT) in patients suspected of having Idiopathic Parkinson Disease (PD) or Atypical Parkinson Syndromes (APS) with as golden standard the clinical diagnosis after 2-year follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

August 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2008

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2012

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

August 22, 2006

Last Update Submit

February 22, 2018

Conditions

Parkinson's DiseaseParkinsonian SyndromeMultiple System AtrophySupranuclear Palsy, ProgressiveEssential TremorVascular ParkinsonismDrug Induced Parkinsonism

Keywords

single photon emission computer tomography (SPECT)transcranial sonographytranscranial duplex scanningparkinson's diseaseatypical parkinson syndromesparkinsonismparkinsoniandiagnosticprogressive supranuclear paralysis

Outcome Measures

Primary Outcomes (1)

  • Concordance of hyperechogenic SN with clinical diagnosis of Parkinson's

    Hyperechogenic substabtia nigra (SN) was assessed at initial visit and after 2 years, patients were re-examined by two movement disorder specialist neurologists for a final clinical diagnosis that served as a surrogate gold standard for our study.

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

250 Patients with unclear parkinsonism at the outpatient clinic

You may qualify if:

  • Patients with unclear parkinsonism at the outpatient clinic

You may not qualify if:

  • Known diagnosis at presentation
  • Life expectation of less than two years because of a non neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, PO Box 5800, 6202 AZ, Netherlands

Location

Related Publications (4)

  • Bouwmans AE, Vlaar AM, Mess WH, Kessels A, Weber WE. Specificity and sensitivity of transcranial sonography of the substantia nigra in the diagnosis of Parkinson's disease: prospective cohort study in 196 patients. BMJ Open. 2013 Apr 2;3(4):e002613. doi: 10.1136/bmjopen-2013-002613. Print 2013.

    PMID: 23550093RESULT

  • Bouwmans AE, Leentjens AF, Mess WH, Weber WE. Abnormal Echogenicity of the Substantia Nigra, Raphe Nuclei, and Third-Ventricle Width as Markers of Cognitive Impairment in Parkinsonian Disorders: A Cross-Sectional Study. Parkinsons Dis. 2016;2016:4058580. doi: 10.1155/2016/4058580. Epub 2016 Jan 10.

    PMID: 26881179RESULT

  • Bouwmans AE, Weber WE, Leentjens AF, Mess WH. Transcranial sonography findings related to depression in parkinsonian disorders: cross-sectional study in 126 patients. PeerJ. 2016 May 18;4:e2037. doi: 10.7717/peerj.2037. eCollection 2016.

    PMID: 27231659RESULT

  • Vlaar AM, Bouwmans AE, van Kroonenburgh MJ, Mess WH, Tromp SC, Wuisman PG, Kessels AG, Winogrodzka A, Weber WE. Protocol of a prospective study on the diagnostic value of transcranial duplex scanning of the substantia nigra in patients with parkinsonian symptoms. BMC Neurol. 2007 Sep 4;7:28. doi: 10.1186/1471-2377-7-28.

    PMID: 17784944DERIVED

Related Links

Biospecimen

Retention: NONE RETAINED

no biocpsicmens

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian DisordersMultiple System AtrophySupranuclear Palsy, ProgressiveEssential TremorDisease

Condition Hierarchy (Ancestors)

Basal 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 SymptomsPathologic Processes

Study Officials

  • Wim EJ Weber, MD PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurology

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 24, 2006

Study Start

September 1, 2006

Primary Completion

September 18, 2008

Study Completion

September 15, 2012

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Dataset is published with PeerJ

Time Frame
Is availabel
Access Criteria
Publicly available
More information

Available IPD Datasets

Individual Participant Data Set Access

Locations

NL(1)