SudoScan as a Biomarker of Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

SudoScan as a Biomarker of Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767037
• Other study ID #: MP-CUSM-15-472
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. PD patients: All will meet criteria for probable PD, according to the new MDS Clinical Diagnostic criteria

2. Non-PD parkinsonism patients: They will have with progressive supranuclear palsy, multiple system atrophy, 'vascular parkinsonism' or corticobasal syndrome. All patients will have parkinsonism according to UK brain bank criteria, with a diagnosis of one of the above conditions made according to gold-standard expert evaluation. No patient will meet MDS Criteria for probable PD.

3. iRBD patients: All patients will have polysomnogram-confirmed RBD according to American Academy of Sleep Medicine Criteria. Patients will be free of parkinsonism and dementia according to neurological examination and will have no untreated sleep apnea, epilepsy, or other abnormalities that could cause dream enactment behavior.

4. Controls: These will be age matched (within 5 years) and sex-matched (with >90% concordance). All controls will have an examination confirming the absence of parkinsonism, and will have no symptoms of REM sleep behavior disorder, as assessed with the RBD1Q and expert interview.

Exclusion Criteria:

1. Diabetes Mellitus - In addition to causing autonomic neuropathy, hyperglycemia itself is known to interfere with results of the sudomotor scan

2. Any preceding diagnosis of autonomic neuropathy (of a cause other than PD)

3. Dementia of severity sufficient to preclude informed consent, MoCA <23.

4. Prescription of medications that directly alter peripheral autonomic function, including beta-blockers, sympatholytics (i.e. clonidine) and non-specific alpha-blockers.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Sudoscan and clinical assessment
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.

Genetic:
• Skin biopsy
Evaluation of the denervation and synuclein deposition of skin biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrochemical skin conductance		up to 6 months
Secondary	PD severity-Hoehn and Yahr stage	PD severity will be assessed with the Hoehn and Yahr	up to 6 months
Secondary	PD severity-MDS-UPDRS	PD severity will be assessed with the MDS-UPDRS	up to 6 months
Secondary	Autonomic symptoms and signs		up to 6 months
Secondary	EKG	Cardiac autonomic denervation will be assessed with analysis of heart rate variability on EKG	up to 6 months
Secondary	Neuropathy	Patients will be screened for neuropathy with the 5-item peripheral neuropathy screening interview	up to 6 months
Secondary	Non-motor symptoms associated with PD	Non-motor variables with be assessed with Parts I and II of the MDS-UPDRS	up to 6 months
Secondary	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	up to 12 months