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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | No Intervention | 30 normal volunteers with age, sex and BMI-match as control group | |
| treatment group | Active Comparator | 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. |
|
| non-treatment group | Sham Comparator | The group will not receive non-rehabilitation treatment, before and after the 12 weeks non-rehabilitation training, should accept MRI and Clinical assessments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Rehabilitation_1 | Unified Parkinson's Disease Rating Scale | 12 weeks |
| Physical Rehabilitation_2 | Walking speed by self-selected gait speed over 10 m |
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Inclusion Criteria:
Exclusion Criteria:
Patients with the following conditions are excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Cheng-Hsien Lu, M.D. | Chang Gung Memorial Hospital | Study Director |
| Jen-Wen Hung, M.D. | Chang Gung Memorial Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| non-rehabilitation treatment | Other | 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. |
|
| 12 weeks |
| Physical Rehabilitation_3 | Walking endurance, by using the 6-minute walk test | 12 weeks |
| Physical Rehabilitation_4 | Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test | 12 weeks |
| Biochemical Analysis | interval change of serum MicroRNA level (increase of decrease) | 18 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |