Parkinson Disease Before and After Medication and Rehabilitation Treatment
|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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Behavioral: Rehabilitation treatment Other: non-rehabilitation treatment||Not Applicable|
(1) 70 patients with PD. (2) 30 age and sex-match controls.
-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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Physical Rehabilitation_1 [ Time Frame: 12 weeks ]Unified Parkinson's Disease Rating Scale
- Physical Rehabilitation_2 [ Time Frame: 12 weeks ]Walking speed by self-selected gait speed over 10 m
- Physical Rehabilitation_3 [ Time Frame: 12 weeks ]Walking endurance, by using the 6-minute walk test
- Physical Rehabilitation_4 [ Time Frame: 12 weeks ]Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test
- Biochemical Analysis [ Time Frame: 18 months ]interval change of serum MicroRNA level (increase of decrease)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672943
|Study Director:||Cheng-Hsien Lu, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Jen-Wen Hung, M.D.||Chang Gung Memorial Hospital|