- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02672943
Parkinson Disease Before and After Medication and Rehabilitation Treatment
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Normal
30 normal volunteers with age, sex and BMI-match as control group
|
|
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.
|
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-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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Physical Rehabilitation_1
Tidsramme: 12 weeks
|
Unified Parkinson's Disease Rating Scale
|
12 weeks
|
Physical Rehabilitation_2
Tidsramme: 12 weeks
|
Walking speed by self-selected gait speed over 10 m
|
12 weeks
|
Physical Rehabilitation_3
Tidsramme: 12 weeks
|
Walking endurance, by using the 6-minute walk test
|
12 weeks
|
Physical Rehabilitation_4
Tidsramme: 12 weeks
|
Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test
|
12 weeks
|
Biochemical Analysis
Tidsramme: 18 months
|
interval change of serum MicroRNA level (increase of decrease)
|
18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Cheng-Hsien Lu, M.D., Chang Gung Memorial Hospital
- Hovedetterforsker: Jen-Wen Hung, M.D., Chang Gung Memorial Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NMRPG8D6031
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Parkinsons sykdom
-
Abbott Medical DevicesBaylor College of Medicine; University of HoustonFullført
-
Bial - Portela C S.A.Fullført
-
Mayo ClinicFullført
-
Ataturk UniversityRekruttering
-
Centre Hospitalier Universitaire, AmiensUkjentParkinson | ImpulskontrollforstyrrelseFrankrike
-
University of Sao Paulo General HospitalInCor Heart InstituteFullførtHjertearytmier | Tilbehør Pathway | Wolf Parkinson White syndromBrasil
-
Institute for Neurodegenerative DisordersFullførtParkinson | Parkinsons syndromForente stater
-
Assistance Publique - Hôpitaux de ParisCentre Hospitalier Universitaire de Pointe-a-PitreFullført
-
University of MinnesotaTilbaketrukketParkinsons sykdom | ParkinsonForente stater
-
National Taiwan University HospitalFullført
Kliniske studier på Rehabilitation treatment
-
Ospedale Generale Di Zona Moriggia-PelasciniFullførtParkinsons sykdom og Pisa-syndromItalia
-
Emory UniversityNational Institute on Aging (NIA)RekrutteringProdromal Alzheimers sykdomForente stater
-
Arizona State UniversityRekrutteringEffekten av START (Startle Rehabilitation Therapy) i behandlingen Slagindusert afasi/apraksi (START)Slag | Afasi | Apraxia av taleForente stater
-
Donders Centre for NeuroscienceRekrutteringSlagFrankrike, Romania, Spania
-
Universidad Pública de NavarraMutua NavarraUkjentSkulderpåvirkning | Rotator Cuff sykdomSpania
-
Arizona State UniversityRekruttering
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalUkjent
-
Arizona State UniversityRekruttering
-
Mauro CrestaniRekruttering
-
Universitätsklinikum Hamburg-EppendorfFullførtSchizofreniTyskland