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

5 agosto 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

288

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Una prova obiettiva basata su immagini per la diagnosi, la diagnosi differenziale e la prognosi della malattia di Parkinson
Lasso di tempo: fine del terzo anno

Quanto segue sarà misurato per le prestazioni diagnostiche della risonanza magnetica di diffusione:

  1. Regressione tra prestazioni cognitive e MRI di diffusione al basale utilizzando la correlazione di Pearson
  2. Tralasciare una convalida incrociata
fine del terzo anno

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
differential diagnosis
Lasso di tempo: end of the second year
To differentiate patient of PD from PD + using diffusion MRI
end of the second year
prognosis
Lasso di tempo: 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
Lasso di tempo: end of the third year
Methods for evaluation of worsening cognitive function in neurodegenerative disease
end of the third year
Imaging
Lasso di tempo: end of the third year
High-quality diffusion MRI and image data restoration
end of the third year
Immagini
Lasso di tempo: fine del terzo anno
Standard di imaging MRI a diffusione di alta qualità, metodi di parcellizzazione e protocollo di elaborazione delle immagini
fine del terzo anno

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2017

Completamento primario (Effettivo)

1 agosto 2018

Completamento dello studio (Effettivo)

31 luglio 2020

Date di iscrizione allo studio

Primo inviato

14 giugno 2020

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2020

Primo Inserito (Effettivo)

15 luglio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 agosto 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 agosto 2021

Ultimo verificato

1 agosto 2021

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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