Parkinson Disease Before and After Medication and Rehabilitation Treatment

NCT02672943 | Unknown

• 1 other identifier: NMRPG8D6031
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Parkinson Disease

Keywords

Parkinson disease; Autonomic nervous system; MicroRNA; Inflammation; Oxidative stress; noradrenergic network; Rehabilitation treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Physical Rehabilitation_1

  12 weeks

• Physical Rehabilitation_2

  12 weeks

• Physical Rehabilitation_3

  12 weeks

• Physical Rehabilitation_4

  12 weeks

• Biochemical Analysis

  18 months

Study Arms (3)

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.

Behavioral: Rehabilitation treatment

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.

Other: non-rehabilitation treatment

Interventions

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.

treatment group

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.

non-treatment group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with the following conditions are excluded:
• 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
• Moderate to severe heart failure (NYHA class III and IV).
• Central or peripheral disorders known to affect autonomic nervous systems.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Parkinson Disease; Inflammation

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Cheng-Hsien Lu, M.D.

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

• Jen-Wen Hung, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: February 3, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: February 3, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share