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The Differential Diagnosis and Prognosis of Idiopathic and Atypical Parkinson Disease by Using Diffusion MRI

5 de agosto de 2021 actualizado por: Wang . Jiun-Jie, Chang Gung Memorial Hospital

The hypothesis is that the differential extent of microstructural damages in the affected brain regions can be specific to the disease of interest and could reflect the clinical severity. Therefore, we propose that the whole brain parcellation of diffusion MRI can be used to improve the diagnosis and prediction of clinical outcomes in Parkinson's Disease.

  1. A regression model between clinical severity and two-year clinical outcomes and diffusion properties from multiple parcellated regions will be developed.
  2. Blind validation will be performed.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Parkinson's disease (PD) is a common progressive neurodegenerative disorder characterized by resting tremor, bradykinesia, restricted mobility, and postural instability. Early diagnosis of PD would be paramount for further treatment and prognosis. The most common neurodegenerative parkinsonian syndrome is known as Parkinson's disease (PD) or idiopathic Parkinson syndrome, if it occurs sporadically (not familial) and its lead clinical symptom is a movement disorder after brainstem-predominant α-synuclein deposition. To distinguish them from Parkinson's disease, other sporadic entities have been named atypical parkinsonian syndromes or atypical parkinsonism. The present review article describes current standards for the diagnosis and treatment of the most important disease entities in this latter group: dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD).

PD is diagnosed mainly by neurologists, based on clinical symptoms. However, there are no objective criteria available for their diagnosis. Although magnetic resonance imaging (MRI) is often employed in conjunction with clinical judgment, the images are mostly used to eliminate other diseases, rather than to confirm the diagnosis. Other imaging methods, such as Positron Emission Tomography or Computed Tomography, may help in the diagnosis of PD but have harmful effects on the human body. MRI image of patients with Parkinson's disease is usually normal. Previous studies have also indicated that brain-related areas, such as the atrophy of basal ganglia, are not observed until a period of disease progression. However, the shrinkage of brain tissue cannot be used as a criterion for the diagnosis of Parkinson's disease, because many other diseases are accompanied by atrophy of brain tissue as well. Furthermore, because human brain cells cannot regenerate, It is too late to diagnose or treat when a large number of nerve cells are apoptotic. Since we expect the function of the diseased cells to change first, therefore, if you can detect changes in the patient's brain microenvironment, it is possible to achieve early detection of Parkinson's disease. Magnetic resonance imaging can detect functional images and display functional changes, thus providing an opportunity to detect abnormalities and diagnose diseases early. One of the key technologies in the measurement of functional images is diffusion magnetic resonance imaging.

Diffusion MRI has been widely utilized to investigate the patterns of neural connectivity. Mean diffusivity (MD) and the directionality (fractional anisotropy (FA)) have been studied in epilepsy, multiple sclerosis, and noticeably in Parkinson's Disease. Owing to their paramount pathogenetic role in Parkinson's disease, the basal ganglia in general and the substantia nigra pars compacta, in particular, have been the subject of intense MRI investigation.

The plan uses standard anatomic labeling (AAL) to perform whole-brain diffusion MRI to obtain diffusion data for the whole brain parcellation. We will use statistical methods to identify the areas affected by each PD's subtype, we will also identify areas that are likely to be related to the severity of the disease, and then combine these areas for linear regression analysis. We anticipate that diffusion magnetic resonance imaging can be used as a differential diagnosis, as well as to define areas of high correlation with clinical severity, and to be used for accurate disease prediction and future development, and to provide physicians and patients with clinically important information.

The program uses diffusion magnetic resonance imaging to assess clinical status and prognosis for Parkinson's disease. Our research goal is

  1. Establish objective and clear imaging diagnostic criteria of diffusion MRI for idiopathic and atypical Parkinson's disease.
  2. Establish objective and clear clinical severity and the prognosis prediction mode of diffusion MRI for idiopathic and atypical Parkinson's disease.

Tipo de estudio

De observación

Inscripción (Actual)

288

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Taoyuan, Taiwán, 333
        • ChangGung Memorial Hospital, Linkou

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

All subjects should meet the following criteria:

  1. Between 50-80 years old
  2. Right-handed
  3. Able to understand study requirements and give informed consent
  4. Agree to return for follow-up checks
  5. Able to suspend intake of medication for at least 12 hours

Descripción

Inclusion Criteria:

-

Exclusion Criteria:

  • Cardiac pacemaker or defibrillator implantation Intracranial metal device implantation
  • Other major systemic diseases, such as renal failure, heart failure, stroke, AMI/unstable angina, poorly controlled diabetes mellitus, poorly controlled hypertension
  • Alcohol or drug abuse
  • Moderate to severe dementia
  • Severe movement disorders
  • Imaging data is similar to a nuclear medical examination, exclusion criteria is any abnormality that may affect cognitive function as reflected in computer tomography or MRI records, such as hydrocephalus or encephalitis. Mild cortical atrophy is acceptable.
  • History of intracranial surgery including thalamotomy, pallidotomy, and/or deep brain stimulation
  • Major physical or neuropsychiatric disorders
  • Structural abnormalities that may cause dementia, such as cortical infarction, tumour, or subdural hematoma
  • Besides medication for Parkinson's Disease, taking other medication with substances that can pass through the blood-brain barrier
  • Besides medication for Parkinson's Disease, taking other medication for more than 10 years
  • Treatments or concurrent illnesses other than Alzheimer's Disease that could interfere with cognitive function
  • Meet the criteria for dementia (DSM-IV)
  • Head trauma with loss of consciousness greater than 10 minutes
  • Severe loss of sensation

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Atypical Parkinson's Disease patients
This group consists of patients includes 35 patients with Progressive Supranuclear Paralysis (PSP), 35 patients with Multiple System Atrophy (MSA), and 35 patients with Cortico-Basal Degeneration (CBD).
Idiopathic Parkinson's Disease patients
This group consists of patients starting from 2012 to 2013 and includes 87 patients with typical Parkinson's Disease (PD)
Healthy volunteers

The 96 healthy volunteers should meet the following criteria:

  1. Between 50-80 years old
  2. Right-handed
  3. MMSE score greater than or equal to 26
  4. Able to understand study requirements and give informed consent

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Una evidencia objetiva basada en imágenes para el diagnóstico, diagnóstico diferencial y pronóstico de la enfermedad de Parkinson
Periodo de tiempo: final del tercer año

Se medirá lo siguiente para el rendimiento diagnóstico de la resonancia magnética de difusión:

  1. Regresión entre el rendimiento cognitivo y la RM de difusión inicial mediante la correlación de Pearson
  2. Dejar uno fuera de la validación cruzada
final del tercer año

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
differential diagnosis
Periodo de tiempo: end of the second year
To differentiate patient of PD from PD + using diffusion MRI
end of the second year
prognosis
Periodo de tiempo: end of the third year
To predict the outcome of patient with PD using the diffusion MRI at baseline
end of the third year
prognosis
Periodo de tiempo: end of the third year
Methods for evaluation of worsening cognitive function in neurodegenerative disease
end of the third year
Imaging
Periodo de tiempo: end of the third year
High-quality diffusion MRI and image data restoration
end of the third year
Imágenes
Periodo de tiempo: final del tercer año
Estándares de imágenes de resonancia magnética de difusión de alta calidad, métodos de parcelación y protocolo de procesamiento de imágenes
final del tercer año

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2017

Finalización primaria (Actual)

1 de agosto de 2018

Finalización del estudio (Actual)

31 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

14 de junio de 2020

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2020

Publicado por primera vez (Actual)

15 de julio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de agosto de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

5 de agosto de 2021

Última verificación

1 de agosto de 2021

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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