Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy

February 11, 2020 updated by: Joerg Spiegel, Universität des Saarlandes

Intra Vitam Diagnosis of Parkinson´s Disease by Means of Submandibular Gland Needle Biopsy

This study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls.

Study Overview

Status

Unknown

Conditions

Detailed Description

Parkinson´s disease (PD) is a neurodegenerative disease which is characterized by a pathological aggregation of α-synuclein. This pathological α-synuclein aggregation results in the formation of Lewy bodies which are used for the histopathological diagnosis of PD. Neuropathological post mortem studies showed that pathological aggregations of α-synuclein may occur also outside the central nervous system in PD, for example in the cardiac plexus, in the major salivary glands and the innervating cervical superior ganglion, in the minor salivary glands, in the adrenal glands and in the mesenteric and pelvic plexus. The finding of pathologically aggregated α-synuclein in the major salivary glands offers the possibility to prove PD intra vitam by means of a small transcutaneous biopsy.

A recent post mortem study in the local Department of Neuropathology found, that there was pathologically aggregated α-synuclein in 12 of 14 patients with diagnosed and neuropathologically confirmed PD, whereas there was no pathologically aggregated α-synuclein in 13 persons without PD.

The present study includes 35 PD patients who underwent submandibular gland needle biopsy. 25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication, serve as controls. Immediately after the biopsy, the obtained submandibular gland tissue is transported to the local Department of Neuropathology for histopathological analysis.

Study Type

Observational

Enrollment (Anticipated)

60

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

  • Germany
    • Saarland
      • Homburg/Saar, Saarland, Germany, D-66421
        • Recruiting
        • Department of Neurology, Saarland University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joerg Spiegel, M.D.

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

Non-Probability Sample

Study Population

Unselected cohort of PD patients

Description

Inclusion Criteria: major patients with Parkinson´s disease (PD)

Exclusion Criteria:

  • Missing consent to participation in the study
  • Pregnancy
  • Indigestibility against local anesthetic
  • Increased risk of bleeding
  • Therapy with an anticoagulant

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

Cohorts and Interventions

Group / Cohort
Participants with Parkinson´s disease.
Participants who fulfilled the diagnostic criteria of Parkinson´s disease.
Participants without a neurological disease
25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologically aggregated α-synuclein in the submandibular gland.
Time Frame: only baseline, no further investigations.
The biopsy was taken with a biopsy needle (diameter 14 g) which was inserted under sonographic control into one of the both submandibular glands. By means of this biopsy method, a biopsy cylinder was obtained from one submandibular gland. The biopsy cylinder which was immediately transported to the Department of Neuropathology. The whole biopsy cylinder was histopathologically investigated for pathologically aggregated alpha-synuclein. Two histopathological results are possible: presence of at least one pathologically aggregated alpha-synuclein in the obtained biopsy cylinder (positive result) or absence of any pathologically aggregated alpha-synuclein in the obtained biopsy cylinder (negative result).
only baseline, no further investigations.

Collaborators and Investigators

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

Sponsor

Universität des Saarlandes

Investigators

  • Principal Investigator: Jörg Spiegel, MD, Department of Neurology, Saarland University, D-66421 Homburg/Saar, Germany

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

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)

February 7, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

February 8, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 234/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Deidentified individual participant data for all measures will be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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