Clinical trial NCT02672943: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Autonomic nervous system
MicroRNA
Inflammation
Oxidative stress
noradrenergic network
Rehabilitation treatment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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:

  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.

Primary outcomes:
measure: Neuroimage
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical Rehabilitation_1
timeFrame: 12 weeks
measure: Physical Rehabilitation_2
timeFrame: 12 weeks
measure: Physical Rehabilitation_3
timeFrame: 12 weeks
measure: Physical Rehabilitation_4
timeFrame: 12 weeks
measure: Biochemical Analysis
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Cheng-Hsien Lu, M.D.
role: STUDY_DIRECTOR
affiliation: Chang Gung Memorial Hospital
name: Jen-Wen Hung, M.D.
role: PRINCIPAL_INVESTIGATOR
References: