Parkinson Disease Before and After Medication and Rehabilitation Treatment

NCT ID: NCT02672943

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-08-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal

30 normal volunteers with age, sex and BMI-match as control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Rehabilitation treatment

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

non-rehabilitation treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng-Hsien Lu, M.D.

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Jen-Wen Hung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Other Identifiers

NMRPG8D6031

Identifier Type: -

Identifier Source: org_study_id