NCT04264273

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Universität des Saarlandes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Parkinson Disease

Timeline

• Start date: 2020-02-07
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-02-11
• Last updated: 2020-02-12

Locations

1 site across 1 country: Germany