SudoScan as a Biomarker of Parkinson's Disease

NCT02767037 | Completed

• 1 other identifier: MP-CUSM-15-472
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Electrochemical skin conductance

  up to 6 months

Secondary Outcomes (7)

• PD severity-Hoehn and Yahr stage

  up to 6 months

• PD severity-MDS-UPDRS

  up to 6 months

• Autonomic symptoms and signs

  up to 6 months

• EKG

  up to 6 months

• Neuropathy

  up to 6 months

Study Arms (4)

Parkinson's disease (PD) patients

ACTIVE COMPARATOR

40 patients will be recruited. All will meet criteria for probable PD, according to the new MDS Clinical Diagnostic criteria. All participants will be 40 or older (young-onset PD includes many genetic causes, which often have normal autonomic function).

Device: Sudoscan and clinical assessment; Genetic: Skin biopsy

parkinsonsism (non-PD) patients

ACTIVE COMPARATOR

20 patients will also be recruited. These will include patients 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.

Device: Sudoscan and clinical assessment; Genetic: Skin biopsy

idiopathic REM sleep behavior disorder patient

ACTIVE COMPARATOR

40 patients will be recruited. 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.

Device: Sudoscan and clinical assessment; Genetic: Skin biopsy

Controls

PLACEBO COMPARATOR

40 controls 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.

Device: Sudoscan and clinical assessment; Genetic: Skin biopsy

Interventions

Sudoscan and clinical assessment DEVICE

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.

Controls; Parkinson's disease (PD) patients; idiopathic REM sleep behavior disorder patient; parkinsonsism (non-PD) patients

Skin biopsy GENETIC

Evaluation of the denervation and synuclein deposition of skin biopsy

Controls; Parkinson's disease (PD) patients; idiopathic REM sleep behavior disorder patient; parkinsonsism (non-PD) patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetes Mellitus - In addition to causing autonomic neuropathy, hyperglycemia itself is known to interfere with results of the sudomotor scan
• Any preceding diagnosis of autonomic neuropathy (of a cause other than PD)
• Dementia of severity sufficient to preclude informed consent, MoCA \<23.
• Prescription of medications that directly alter peripheral autonomic function, including beta-blockers, sympatholytics (i.e. clonidine) and non-specific alpha-blockers.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: May 10, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share