Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2018-05-31

Brief Summary

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The purpose of this study is to perform biopsies of one of the glands that make saliva. The biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's disease. This study will determine whether it is possible to do a second biopsy a few years after a previous biopsy and determine whether there are changes in the biopsy that would allow for analysis of disease progression.

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Detailed Description

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Tissue biopsies documenting the presence and density of Lewy type synucleinopathy (LTS) in living patients with probable Parkinsons disease (PD) would be extremely valuable as a diagnostic test, as a marker of molecular therapeutic target engagement and as a progression marker. Based on recent data from our group with both early and advanced PD patients, we propose to perform a second transcutaneous submandibular gland (SMG) needle core biopsy in 12 patients who have previously been biopsied and had LTS present in their SMG tissue.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Submandibular gland biopsy

No treatment is being used in this study. Study participants will have bilateral submandibular gland biopsies.

Group Type EXPERIMENTAL

Submandibular gland biopsy

Intervention Type PROCEDURE

Needle biopsies of the right and left submandibular glands

Interventions

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Submandibular gland biopsy

Needle biopsies of the right and left submandibular glands

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. PD patients ages up to age 85.
2. Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported

Exclusion Criteria

1. Evidence for dementia that would preclude the patient from signing informed consent
2. History of bleeding diathesis or hematologic disorders
3. Medically unable to undergo a core needle biopsy of the submandibular gland
4. Prior treatment of the submandibular gland with botulinum toxin injections.
5. History of past or current acute infection or abscess of the submandibular gland.
6. History of past or current neoplastic process within the submandibular gland.
7. History of peripheral neuropathy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No