Currently, there is no clear diagnostic test that can be used to confirm the diagnosis of Parkinson's disease, or a biomarker that can track its progression. Patients with Parkinson's have many abnormalities of the autonomic nervous system, which may be related to Parkinson's changes outside of the brain. A new device called the SudoScan, which measures autonomic sweating changes, may be a simple way to test for autonomic changes in Parkinson's. The investigator plan to see whether SudoScan can identify Parkinson's disease and whether SudoScan abnormalities might be present even in early (prodromal) Parkinson's stages. The investigator will assess SudoScan in a group of Parkinson's patients, normal healthy controls, patients with non-Parkinson's neurodegeneration, and patients with REM sleep behavior disorder (an early/prodromal Parkinson's state). Abnormalities will be correlated with standard autonomic tests and with skin biopsy findings Parkinson's degeneration in the peripheral autonomic fibers. If the investigator can find a reliable way to diagnose and follow Parkinson's disease, he will be able to correctly identify Parkinson's (even in its earliest stages). This will improve the chance to find protective treatments against Parkinson's, by preventing false diagnosis and by providing a new marker to track disease progression. If successful, the investigator will aim to validate the findings on a large sample of Parkinson's and also to track changes over time in the original cohorts
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
150
The primary variable will be electrochemical skin conductance (ESC), as assessed by the SudoScan (Impeto Medical, France). The clinical assessment will include a neurological evaluation (including MDS-UPDRS), evaluation of autonomic symptoms and signs, EKG, evaluation of possible neuropathy and evaluation of non-motor variables.
Evaluation of the denervation and synuclein deposition of skin biopsy
Electrochemical skin conductance
Time frame: up to 6 months
PD severity-Hoehn and Yahr stage
PD severity will be assessed with the Hoehn and Yahr
Time frame: up to 6 months
PD severity-MDS-UPDRS
PD severity will be assessed with the MDS-UPDRS
Time frame: up to 6 months
Autonomic symptoms and signs
Time frame: up to 6 months
EKG
Cardiac autonomic denervation will be assessed with analysis of heart rate variability on EKG
Time frame: up to 6 months
Neuropathy
Patients will be screened for neuropathy with the 5-item peripheral neuropathy screening interview
Time frame: up to 6 months
Non-motor symptoms associated with PD
Non-motor variables with be assessed with Parts I and II of the MDS-UPDRS
Time frame: up to 6 months
Skin biopsy
Denervation and synuclein deposition of skin biopsy will include staining for proteinase-k-resistant synuclein (5C12 antibody) and neuronal markers to determine density of peripheral innervation
Time frame: up to 12 months
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