Parkinson Disease Before and After Medication and Rehabilitation Treatment

Chang Gung Memorial Hospital60 enrolled

Overview

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).

(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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Rehabilitation treatmentBEHAVIORAL

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.

non-rehabilitation treatmentOTHER

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

Physical Rehabilitation_1

Unified Parkinson's Disease Rating Scale

Time frame: 12 weeks

Physical Rehabilitation_2

Walking speed by self-selected gait speed over 10 m

Time frame: 12 weeks

Physical Rehabilitation_3

Walking endurance, by using the 6-minute walk test

Time frame: 12 weeks

Physical Rehabilitation_4

Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test

Time frame: 12 weeks

Biochemical Analysis

interval change of serum MicroRNA level (increase of decrease)

Time frame: 18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.