Parkinson Disease Before and After Medication and Rehabilitation Treatment
31. januar 2016 opdateret af: Chang Gung Memorial Hospital
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
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).
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
(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
- 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
60
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Normal
30 normal volunteers with age, sex and BMI-match as control group
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Aktiv komparator: 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.
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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.
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Sham-komparator: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neuroimage
Tidsramme: 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
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Rehabilitation_1
Tidsramme: 12 weeks
|
Unified Parkinson's Disease Rating Scale
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12 weeks
|
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Physical Rehabilitation_2
Tidsramme: 12 weeks
|
Walking speed by self-selected gait speed over 10 m
|
12 weeks
|
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Physical Rehabilitation_3
Tidsramme: 12 weeks
|
Walking endurance, by using the 6-minute walk test
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12 weeks
|
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Physical Rehabilitation_4
Tidsramme: 12 weeks
|
Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test
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12 weeks
|
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Biochemical Analysis
Tidsramme: 18 months
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interval change of serum MicroRNA level (increase of decrease)
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18 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Cheng-Hsien Lu, M.D., Chang Gung Memorial Hospital
- Ledende efterforsker: Jen-Wen Hung, M.D., Chang Gung Memorial Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2016
Primær færdiggørelse (Forventet)
1. august 2016
Studieafslutning (Forventet)
1. august 2017
Datoer for studieregistrering
Først indsendt
1. april 2015
Først indsendt, der opfyldte QC-kriterier
31. januar 2016
Først opslået (Skøn)
3. februar 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. januar 2016
Sidst verificeret
1. januar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NMRPG8D6031
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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