Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes

February 22, 2018 updated by: Wim Weber, Maastricht University Medical Center

Diagnostic Value Transcranial Duplex Scanning and Single Photon Emission Tomography in Patients Suspected of Having Idiopathic Parkinson Disease or Atypical Parkinson Syndromes

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.

Study Overview

Status

Completed

Conditions

Detailed Description

PD is a progressive neurodegenerative illness that affects about 50.000 people in the Netherlands. Diagnosis is based on clinical criteria. However, purely on clinical grounds, especially in the early stage, it is not possible to differentiate PD from other parkinsonian syndromes like multiple system atrophy, Progressive Supranuclear Palsy, vascular parkinsonism, drug induced parkinsonism and essential tremor. Accurate differentiation is important because treatment and prognosis varies between the different syndromes.

At present SPECT scans are used mostly. However the SPECT is only used in the minority of the patients suspected of PD mainly because the costs and the discussion about their sensitivity and specificity to diagnose PD. We are currently finishing a meta-analysis on the diagnostic value of the SPECT in patients with parkinsonian diseases.

Recently an alternative method to visualise the alterations in the cerebral dopaminergic pathways of PD patients has been proposed: TCD of the substantia nigra in the brainstem. This technique has high inter-observer reliability. Becker discovered in 1994 that patients with PD had bilateral hyperechogenicity of the substantia nigra. Neuropathological studies confirm the increased echogenicity is because of iron deposition. However the reason of the increased level of iron is unknown.

Several publications confirm the observation that up to 90% of PD patients have increased echogenicity of the substantia nigra. In healthy subjects and in patients with essential tremor this hyperintensity of the substantia nigra is only found in 10%. However 60% of the healthy subjects with increased echogenicity also have decreased nigra-striatal function on (18)-F-dopa-PET. So TCD might possibly be an early (presymptomatic) marker for PD.

If substantia nigra scanning is combined with scanning of the nucleus lentiformis, the differentiation between PD and APS is increased. Another advantage is that with the same technique the raphe nuclei can be made visible. Several studies confirm the echogenicity of raphe nuclei is decreased in PD patients with a depression.

Our own experience suggests that the positive predictive value of this technique nears that of SPECT scans. In our pilot study with 45 patients with PD or APS who underwent SPECT and TCS we found a positive prediction value of 95%. This would predict that, if TCE is compatible with PD, a SPECT does not provide additional information; so in theory one might reduce the amount of SPECT's in almost 50% of cases.

A direct compare of the diagnostic accuracy as to PD between duplex and SPECT scans has until now not been made. Our hypothesis is that the TCD of substantia nigra duplex scanning is an accurate diagnostic tool and deserves a place in the diagnostic work-up of PD/Parkinsonism patients and diagnostically efficient enough to replace 50% of SPECT scans. In comparison with SPECT duplex scanning is less costly (respectively 80 euro and 400 euro for each SPECT) and more comfortable for the patient.

Methods:

Subjects:

250 consecutive patients with new parkinsonian complaints in the out-patient clinic of our university hospital (Maastricht) and a local hospital.

Study design:

The investigator will give a clinical diagnosis at the first visit. All subjects undergo SPECT and duplex scanning, both tests will be judged blindly for the clinical diagnosis. After two years follow-up, all patients will be seen by the investigator and again a clinical diagnosis will be made (investigator is blinded for the results of the duplex and SPECT). At the end of the follow-up the sensitivity and specificity of the first clinical judgement, duplex and SPECT can be calculated. The golden standard is the clinical diagnosis at the end of the follow-up.

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • PO Box 5800
      • Maastricht, PO Box 5800, Netherlands, 6202 AZ
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

250 Patients with unclear parkinsonism at the outpatient clinic

Description

Inclusion Criteria:

  • Patients with unclear parkinsonism at the outpatient clinic

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of hyperechogenic SN with clinical diagnosis of Parkinson's
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Funding: Stichting Internationaal Parkinson Fonds, The Netherlands

Investigators

  • Principal Investigator: Wim EJ Weber, MD PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2006

Primary Completion (Actual)

September 18, 2008

Study Completion (Actual)

September 15, 2012

Study Registration Dates

First Submitted

August 22, 2006

First Submitted That Met QC Criteria

August 22, 2006

First Posted (Estimate)

August 24, 2006

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Vlaar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Dataset is published with PeerJ

IPD Sharing Time Frame

Is availabel

IPD Sharing Access Criteria

Publicly available

Study Data/Documents

  1. Individual Participant Data Set

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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