Parkinson Disease Before and After Medication and Rehabilitation Treatment

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02672943
• Other study ID #: NMRPG8D6031
• Status: Active, not recruiting
• Phase: N/A
• First received: April 1, 2015
• Last updated: January 31, 2016
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Physical Rehabilitation_1	Unified Parkinson's Disease Rating Scale	12 weeks	Yes
Secondary	Physical Rehabilitation_2	Walking speed by self-selected gait speed over 10 m	12 weeks	Yes
Secondary	Physical Rehabilitation_3	Walking endurance, by using the 6-minute walk test	12 weeks	Yes
Secondary	Physical Rehabilitation_4	Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test	12 weeks	Yes
Secondary	Biochemical Analysis	interval change of serum MicroRNA level (increase of decrease)	18 months	Yes