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Completed

NCT Number: NCT02767037

SudoScan as a Biomarker of Parkinson's Disease

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Skin biopsy

Genetic

Evaluation of the denervation and synuclein deposition of skin biopsy

Primary outcomes

  1. Electrochemical skin conductance

    Time frame: up to 6 months

Secondary outcomes

  1. PD severity-Hoehn and Yahr stage

    Time frame: up to 6 months

    PD severity will be assessed with the Hoehn and Yahr

  2. PD severity-MDS-UPDRS

    Time frame: up to 6 months

    PD severity will be assessed with the MDS-UPDRS

  3. Autonomic symptoms and signs

    Time frame: up to 6 months

  4. EKG

    Time frame: up to 6 months

    Cardiac autonomic denervation will be assessed with analysis of heart rate variability on EKG

  5. Neuropathy

    Time frame: up to 6 months

    Patients will be screened for neuropathy with the 5-item peripheral neuropathy screening interview

  6. Non-motor symptoms associated with PD

    Time frame: up to 6 months

    Non-motor variables with be assessed with Parts I and II of the MDS-UPDRS

  7. Skin biopsy

    Time frame: up to 12 months

    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

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 10, 2016
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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