An observational study in Parkinson Disease, sponsored by Universität des Saarlandes. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Universität des Saarlandes · Observational
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 60 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Universität des Saarlandes is the lead sponsor of 64 studies on the registry; 16 are open to participants now.
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Unselected cohort of PD patients
Inclusion Criteria: major patients with Parkinson´s disease (PD)
Exclusion Criteria:
Participants who fulfilled the diagnostic criteria of Parkinson´s disease.
25 neurologically healthy patients of the local otolaryngological clinic, in whom submandibular gland needle biopsy was performed due to a clinical indication.
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).
Time frame: only baseline, no further investigations.
Plan to share: Undecided — Deidentified individual participant data for all measures will be made available.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Universität des Saarlandes