- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
(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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Normal
30 normal volunteers with age, sex and BMI-match as control group
|
|
Comparador activo: 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.
|
Comparador falso: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Neuroimage
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Physical Rehabilitation_1
Periodo de tiempo: 12 weeks
|
Unified Parkinson's Disease Rating Scale
|
12 weeks
|
Physical Rehabilitation_2
Periodo de tiempo: 12 weeks
|
Walking speed by self-selected gait speed over 10 m
|
12 weeks
|
Physical Rehabilitation_3
Periodo de tiempo: 12 weeks
|
Walking endurance, by using the 6-minute walk test
|
12 weeks
|
Physical Rehabilitation_4
Periodo de tiempo: 12 weeks
|
Static and dynamic balance control, by using Biodex Balance System and Timed Up and Go test
|
12 weeks
|
Biochemical Analysis
Periodo de tiempo: 18 months
|
interval change of serum MicroRNA level (increase of decrease)
|
18 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Cheng-Hsien Lu, M.D., Chang Gung Memorial Hospital
- Investigador principal: Jen-Wen Hung, M.D., Chang Gung Memorial Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NMRPG8D6031
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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