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Parkinson Disease Before and After Medication and Rehabilitation Treatment

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ClinicalTrials.gov Identifier: NCT02672943
Recruitment Status : Unknown
Verified January 2016 by Chang Gung Memorial Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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).

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Rehabilitation treatment Other: non-rehabilitation treatment Not Applicable

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

  1. To define the effect of norepinephrine network to autonomic dysfunction in PD
  2. To define the effect of peripheral microRNA level to norepinephrine network in PD
  3. 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.
  4. According to previous results, to verify the role of norepinephrine network and autonomic dysfunction in long-term PD evolution.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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 Start Date : January 2016
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Normal
30 normal volunteers with age, sex and BMI-match as control group
Active Comparator: treatment 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.
Behavioral: Rehabilitation treatment
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.

Sham Comparator: non-treatment group
The group will not receive non-rehabilitation treatment, before and after the 12 weeks non-rehabilitation training, should accept MRI and Clinical assessments.
Other: non-rehabilitation treatment
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 Measures :
  1. Neuroimage [ Time Frame: 12 weeks ]
    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 :
  1. Physical Rehabilitation_1 [ Time Frame: 12 weeks ]
    Unified Parkinson's Disease Rating Scale

  2. Physical Rehabilitation_2 [ Time Frame: 12 weeks ]
    Walking speed by self-selected gait speed over 10 m

  3. Physical Rehabilitation_3 [ Time Frame: 12 weeks ]
    Walking endurance, by using the 6-minute walk test

  4. Physical Rehabilitation_4 [ Time Frame: 12 weeks ]
    Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test

  5. Biochemical Analysis [ Time Frame: 18 months ]
    interval change of serum MicroRNA level (increase of decrease)



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672943


Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Director: Cheng-Hsien Lu, M.D. Chang Gung Memorial Hospital
Principal Investigator: Jen-Wen Hung, M.D. Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02672943    
Other Study ID Numbers: NMRPG8D6031
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Gung Memorial Hospital:
Parkinson disease
Autonomic nervous system
MicroRNA
Inflammation
Oxidative stress
noradrenergic network
Rehabilitation treatment
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases