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Parkinson Disease Before and After Medication and Rehabilitation Treatment

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation treatment
non-rehabilitation treatment
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Autonomic nervous system, MicroRNA, Inflammation, Oxidative stress, noradrenergic network, Rehabilitation treatment

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In this study, the patients should be 40-75 years of age and identified as PD. PD patients with an early clinical stage (Hoehn and Yahr stage 1-3) will be enrolled in this study. The informed written consent which is approved by Ethics Committee of our hospital will be obtained from the patient or their family.

Exclusion Criteria:

  • Patients with the following conditions are excluded:

    1. Atherosclerotic narrowing on intracranial and extracranial vessels (>50% stenosis) with or without evidence of old cerebral infarctions, coronary artery diseases status post percutaneous transluminal coronary angioplasty or bypass surgery and renal failure requiring hemodialysis or peritoneal dialysis
    2. Moderate to severe heart failure (NYHA class III and IV).
    3. Central or peripheral disorders known to affect autonomic nervous systems.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Sham Comparator

    Arm Label

    Normal

    treatment group

    non-treatment group

    Arm Description

    30 normal volunteers with age, sex and BMI-match as control group

    The Rehabilitation treatment group will receive rehabilitation training once per day, 3 days per week, for 12 weeks. The duration of each session is about 1 hour. Participants will first receive relaxation exercises, positioning and self-stretch exercises (emphasizing on spinal mobility and flexor muscle groups of limbs and trunk) for 15 minutes. Then they will have balance training for 20 minutes. The investigators will use goal-directed tasks, such as different types of ball games, for balance training. At the end, participants will receive walking exercise for 20 minutes, and cool down exercises for 5 minutes.

    The group will not receive non-rehabilitation treatment, before and after the 12 weeks non-rehabilitation training, should accept MRI and Clinical assessments.

    Outcomes

    Primary Outcome Measures

    Neuroimage
    Conventional MRI, Rest function MRI Image Data Preprocessing, Assessment of cerebral blood flow with Arterial Spin Labeling (ASL) MRI and Chemical Exchange Saturation Transfer

    Secondary Outcome Measures

    Physical Rehabilitation_1
    Unified Parkinson's Disease Rating Scale
    Physical Rehabilitation_2
    Walking speed by self-selected gait speed over 10 m
    Physical Rehabilitation_3
    Walking endurance, by using the 6-minute walk test
    Physical Rehabilitation_4
    Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test
    Biochemical Analysis
    interval change of serum MicroRNA level (increase of decrease)

    Full Information

    First Posted
    April 1, 2015
    Last Updated
    January 31, 2016
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02672943
    Brief Title
    Parkinson Disease Before and After Medication and Rehabilitation Treatment
    Official Title
    The Role of Noradrenergic Network, and Its Association With Autonomous Dysfunction,Cerebral Autoregulation and microRNA in Parkinson Disease Before and After Medication and Rehabilitation Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this three-year project, our research teams are going to consecutively explore these important clinical, drug and physical rehabilitation treatment effects, noradrenergic network, autonomic dysfunction and microRNA signalling data as well as the correlations between them in early Parkinson Disease (PD) patients. The investigators hypothesize that the explorations of the above insights are unique and can provide an important source data for Taiwanese Parkinson Disease (PD).
    Detailed Description
    (1) 70 patients with PD. (2) 30 age and sex-match controls. Methods: -1st year To built up the biobank of 30 early PD patients (Hoehn and Yahr stage 1-3) and 30 health controls in all examination. The PD patients will accept the MRI, autonomic dysfunction, and peripheral microRNA examination and their correlations among each other at least 12 hours after the least medication. -2nd year Second year, the investigators will follow-up the 30 PD patients enrolled in the 1st years. The PD patients will receive studies to evaluate the pharmacokinetics effect before medication, including MRI, autonomic dysfunction, and peripheral microRNA examination. -3rd year the investigators will study the rehabilitation effect in PD (3 days per week, for 12 weeks). 30 PD with rehabilitation and 30 PD without rehabilitation will be enrolled and compared their difference in MRI study, autonomic dysfunction, and peripheral microRNA examination before and after 3 month follow-up. Goals To define the effect of norepinephrine network to autonomic dysfunction in PD To define the effect of peripheral microRNA level to norepinephrine network in PD To associate drug/physical rehabilitation effect to alteration of norepinephrine network, autonomic dysfunction, and peripheral microRNA and their interactions to striatal dopaminergic network in PD. According to previous results, to verify the role of norepinephrine network and autonomic dysfunction in long-term PD evolution.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson disease, Autonomic nervous system, MicroRNA, Inflammation, Oxidative stress, noradrenergic network, Rehabilitation treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal
    Arm Type
    No Intervention
    Arm Description
    30 normal volunteers with age, sex and BMI-match as control group
    Arm Title
    treatment group
    Arm Type
    Active Comparator
    Arm Description
    The Rehabilitation treatment group will receive rehabilitation training once per day, 3 days per week, for 12 weeks. The duration of each session is about 1 hour. Participants will first receive relaxation exercises, positioning and self-stretch exercises (emphasizing on spinal mobility and flexor muscle groups of limbs and trunk) for 15 minutes. Then they will have balance training for 20 minutes. The investigators will use goal-directed tasks, such as different types of ball games, for balance training. At the end, participants will receive walking exercise for 20 minutes, and cool down exercises for 5 minutes.
    Arm Title
    non-treatment group
    Arm Type
    Sham Comparator
    Arm Description
    The group will not receive non-rehabilitation treatment, before and after the 12 weeks non-rehabilitation training, should accept MRI and Clinical assessments.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Rehabilitation treatment
    Intervention Description
    The walking exercise will be aerobic with a Borg rating perceived exertion around 11-14 scales. Before and after the 12 weeks rehabilitation training, should accept MRI and Clinical assessments.
    Intervention Type
    Other
    Intervention Name(s)
    non-rehabilitation treatment
    Intervention Description
    The walking exercise will be aerobic with a Borg rating perceived exertion around 11-14 scales. Before and after the 12 weeks non-rehabilitation training, should accept MRI and Clinical assessments.
    Primary Outcome Measure Information:
    Title
    Neuroimage
    Description
    Conventional MRI, Rest function MRI Image Data Preprocessing, Assessment of cerebral blood flow with Arterial Spin Labeling (ASL) MRI and Chemical Exchange Saturation Transfer
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Physical Rehabilitation_1
    Description
    Unified Parkinson's Disease Rating Scale
    Time Frame
    12 weeks
    Title
    Physical Rehabilitation_2
    Description
    Walking speed by self-selected gait speed over 10 m
    Time Frame
    12 weeks
    Title
    Physical Rehabilitation_3
    Description
    Walking endurance, by using the 6-minute walk test
    Time Frame
    12 weeks
    Title
    Physical Rehabilitation_4
    Description
    Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test
    Time Frame
    12 weeks
    Title
    Biochemical Analysis
    Description
    interval change of serum MicroRNA level (increase of decrease)
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In this study, the patients should be 40-75 years of age and identified as PD. PD patients with an early clinical stage (Hoehn and Yahr stage 1-3) will be enrolled in this study. The informed written consent which is approved by Ethics Committee of our hospital will be obtained from the patient or their family. Exclusion Criteria: Patients with the following conditions are excluded: Atherosclerotic narrowing on intracranial and extracranial vessels (>50% stenosis) with or without evidence of old cerebral infarctions, coronary artery diseases status post percutaneous transluminal coronary angioplasty or bypass surgery and renal failure requiring hemodialysis or peritoneal dialysis Moderate to severe heart failure (NYHA class III and IV). Central or peripheral disorders known to affect autonomic nervous systems.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cheng-Hsien Lu, M.D.
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Jen-Wen Hung, M.D.
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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