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

NCT04264273 | Unknown

• 1 other identifier: 234/19
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Alpha synuclein

Outcome Measures

Primary Outcomes (1)

• Pathologically aggregated α-synuclein in the submandibular gland.

  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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unselected cohort of PD patients

You may not qualify if:

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

Sponsors & Collaborators

• Universität des Saarlandes: lead

Study Sites (1)

Department of Neurology, Saarland University

Homburg/Saar, Saarland, D-66421, Germany

RECRUITING

Related Publications (5)

• Adler CH, Dugger BN, Hentz JG, Hinni ML, Lott DG, Driver-Dunckley E, Mehta S, Serrano G, Sue LI, Duffy A, Intorcia A, Filon J, Pullen J, Walker DG, Beach TG. Peripheral Synucleinopathy in Early Parkinson's Disease: Submandibular Gland Needle Biopsy Findings. Mov Disord. 2016 Feb;31(2):250-6. doi: 10.1002/mds.26476. Epub 2016 Jan 22.

  PMID: 26799362 BACKGROUND

• Beach TG, Adler CH, Dugger BN, Serrano G, Hidalgo J, Henry-Watson J, Shill HA, Sue LI, Sabbagh MN, Akiyama H; Arizona Parkinson's Disease Consortium. Submandibular gland biopsy for the diagnosis of Parkinson disease. J Neuropathol Exp Neurol. 2013 Feb;72(2):130-6. doi: 10.1097/NEN.0b013e3182805c72.

  PMID: 23334596 BACKGROUND

• Del Tredici K, Hawkes CH, Ghebremedhin E, Braak H. Lewy pathology in the submandibular gland of individuals with incidental Lewy body disease and sporadic Parkinson's disease. Acta Neuropathol. 2010 Jun;119(6):703-13. doi: 10.1007/s00401-010-0665-2. Epub 2010 Mar 14.

  PMID: 20229352 BACKGROUND

• Orimo S, Uchihara T, Nakamura A, Mori F, Kakita A, Wakabayashi K, Takahashi H. Axonal alpha-synuclein aggregates herald centripetal degeneration of cardiac sympathetic nerve in Parkinson's disease. Brain. 2008 Mar;131(Pt 3):642-50. doi: 10.1093/brain/awm302. Epub 2007 Dec 13.

  PMID: 18079166 BACKGROUND

• Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.

  PMID: 9278044 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue of the submandibular gland which is obtained by means of needle biopsy from the submandibular gland

MeSH Terms

Conditions

Parkinson Disease; Parkinson Disease 4, Autosomal Dominant Lewy Body

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jörg Spiegel, MD

  Department of Neurology, Saarland University, D-66421 Homburg/Saar, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Spiegel, MD

CONTACT

+49 6841 1624101; joerg.spiegel@uks.eu

Walter Schulz-Schaeffer, MD

CONTACT

+49 6841 1623865; Walter.Schulz-Schaeffer@uks.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant medical director

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 11, 2020
• Study Start: February 7, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

DE (1)