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SudoScan as a Biomarker of Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sudoscan and clinical assessment
Skin biopsy
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Parkinson's Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Parkinson's disease (PD) patients

    parkinsonsism (non-PD) patients

    idiopathic REM sleep behavior disorder patient

    Controls

    Arm Description

    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).

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Electrochemical skin conductance

    Secondary Outcome Measures

    PD severity-Hoehn and Yahr stage
    PD severity will be assessed with the Hoehn and Yahr
    PD severity-MDS-UPDRS
    PD severity will be assessed with the MDS-UPDRS
    Autonomic symptoms and signs
    EKG
    Cardiac autonomic denervation will be assessed with analysis of heart rate variability on EKG
    Neuropathy
    Patients will be screened for neuropathy with the 5-item peripheral neuropathy screening interview
    Non-motor symptoms associated with PD
    Non-motor variables with be assessed with Parts I and II of the MDS-UPDRS
    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

    Full Information

    First Posted
    January 22, 2016
    Last Updated
    October 29, 2018
    Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02767037
    Brief Title
    SudoScan as a Biomarker of Parkinson's Disease
    Official Title
    SudoScan as a Biomarker of Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Parkinson's disease (PD) patients
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    parkinsonsism (non-PD) patients
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    idiopathic REM sleep behavior disorder patient
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Controls
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Sudoscan and clinical assessment
    Intervention Description
    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.
    Intervention Type
    Genetic
    Intervention Name(s)
    Skin biopsy
    Intervention Description
    Evaluation of the denervation and synuclein deposition of skin biopsy
    Primary Outcome Measure Information:
    Title
    Electrochemical skin conductance
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    PD severity-Hoehn and Yahr stage
    Description
    PD severity will be assessed with the Hoehn and Yahr
    Time Frame
    up to 6 months
    Title
    PD severity-MDS-UPDRS
    Description
    PD severity will be assessed with the MDS-UPDRS
    Time Frame
    up to 6 months
    Title
    Autonomic symptoms and signs
    Time Frame
    up to 6 months
    Title
    EKG
    Description
    Cardiac autonomic denervation will be assessed with analysis of heart rate variability on EKG
    Time Frame
    up to 6 months
    Title
    Neuropathy
    Description
    Patients will be screened for neuropathy with the 5-item peripheral neuropathy screening interview
    Time Frame
    up to 6 months
    Title
    Non-motor symptoms associated with PD
    Description
    Non-motor variables with be assessed with Parts I and II of the MDS-UPDRS
    Time Frame
    up to 6 months
    Title
    Skin biopsy
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified clinical data will be shared with the Michael J. Fox Foundation (the study funder) for Parkinson's research. These data may be kept for storage at a central repository either hosted by the Michael J. Fox Foundation, its collaborators, or consultants and will be kept indefinitely. In order to advance scientific discoveries, your de-identified data will be made publically available (with no personal identifying information) for the intended use of research in Parkinson's disease as well as other biomedical research studies that may not be related to Parkinson's disease.

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    SudoScan as a Biomarker of Parkinson's Disease

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