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

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Brief Title

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

Official Title

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

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.
    

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


Primary Outcome

Concordance of hyperechogenic SN with clinical diagnosis of Parkinson's


Condition

Parkinson's Disease



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

196

Start Date

September 1, 2006

Completion Date

September 15, 2012

Primary Completion Date

September 18, 2008

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Wim EJ Weber, MD PhD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT00368199

Organization ID

1-Vlaar


Responsible Party

Principal Investigator

Study Sponsor

Maastricht University Medical Center

Collaborators

 Funding: Stichting Internationaal Parkinson Fonds, The Netherlands

Study Sponsor

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


Verification Date

February 2018