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Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery

6 de agosto de 2019 atualizado por: Sun Im, The Catholic University of Korea
The purpose of this study is to assess the association of genetic polymorphism such as the Brain-derived Neurotrophic factor (BDNF), in neurogenic dysphagia in those with brain lesion.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Neurogenic dysphagia attributable to acquired brain lesions, such as after stroke and after traumatic brain injury, are one of leading causes of chronic disability world widely and it is expected to substantially increase over the next two decades. Among various sequalae, dysphagia can be observed in about 40% -60% of post-stroke patients and 20% -30% of them might suffer from recurrent aspiration pneumonia and may inhibit recovery and can even lead to death. Recovery after brain lesions can be explained by specific molecular events. It is proven that Genetic polymorphisms associated with impaired neural repair or plasticity might reduce recovery from stroke. Not only for the motor recovery, but genetic polymorphism is also crucial for the recovery of swallowing after stroke, however, only limited amount of studies are available. Therefore, it is urgent to determine whether the recovery of swallowing disorders after stroke is affected by the inherent polymorphism of the patient, whether the degree of recovery and brain plasticity associated with swallowing depend on the gene characteristics and polymorphism of the patient and whether recovery in swallowing parallel to the recovery observed in other functional areas (ie. hand recovery, truncal control recovery, ADL recovery).

Based on the results of this study, results will be expected to help provide genetically tailored diagnosis and prognostication according to the gene polymorphism of the patient. Optimized treatment of the patient is expected to contribute to prevention of respiratory complications and improve functional outcome related to swallowing after stroke.

Tipo de estudo

Observacional

Inscrição (Real)

220

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Republica da Coréia
    • Gyonggido
      • Bucheon, Gyonggido, Republica da Coréia, 14647
        • Department of Rehabilitation Medicine
    • Kyounggido
      • Bucheon, Kyounggido, Republica da Coréia
        • Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Patients who had were diagnosed with first dysphagia and referred to Department of Rehabilitation( in Bucheon St. Mary's Hospital and National Traffic Injury Rehabilitation Hospital) with medical records up to 6 months after onset of brain lesion

Descrição

Inclusion Criteria

  1. Patients who had been diagnosed with first ever brain lesions ( stroke and traumatic brain lessons) and referred to Department of Rehabilitation( in Bucheon St. Mary's Hospital and National Traffic Injury Rehabilitation Hospital)
  2. Patients who were hospitalized for 30 days and were followed up at 3 months after the onset of brain lesions
  3. Patients who agree to participate in the study or if the guardian or legal representative agrees only if the patient has difficulties in consenting or consenting to participate directly in the language disability.
  4. In the case of a suspected feeding swallowing disorder in the patient, the patient should be confirmed by VFSS(Videofluoroscopic Swallwing Study) or FEES(Fiberoptic Endoscopic Evaluation of Swallowing)

Exclusion Criteria

  1. Patients who do not meet the above criteria
  2. Patients with difficulty in collecting blood for genetic testing
  3. Patients who were not able to followed-up for 6 months(follow up loss patients)
  4. Patients with long-term Parkinson's disease, Alzheimer's disease, Guillain-Barre syndrome, myasthenia gravis syndrome, etc.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Dysphagia patients
Patients who had been diagnosed with neurogenic dysphagia related to either stroke or traumatic brain injury at two university affiliated hospitals

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Functional Oral Intake Scale(FOIS)
Prazo: initial 4 weeks,3months after onset
Functional oral intake scale(FOIS) is categorical scale range from 1 indicating severe dysphagia and 7 indicating safe oral feeding. Higher change in FOIS indicates improvement of patient's swallowing function.
initial 4 weeks,3months after onset

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Berg Balance Scale(BBS)
Prazo: initial 4 weeks, 3 months after onset
BBS is a scale that measure person's static and dynamic balance abilities, ranging from 0 to 56 where 56 indicated independence in gait and 0 means unable to gait. Higher change in Berg Balance Scale means improved patient's mobility.
initial 4 weeks, 3 months after onset
Change in Medical Research Council(MRC) grade Disability level
Prazo: initial 4 weeks, 3 months after onset

The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

It is categorical value with the the scale running from 0-6, running from perfect health without symptoms to death.
initial 4 weeks, 3 months after onset
Change in K-MBI(Korean Modified Barthel Index)
Prazo: initial 4 weeks, 3 months after onset
The Barthel scale or Barthel ADL index is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. Higher scores indicates indolence in ADL activities.
initial 4 weeks, 3 months after onset
Change in FAC(Functional Ambulatory Category)
Prazo: initial 4 weeks, 3 months after onset
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device . Higher scores indicate better performance.
initial 4 weeks, 3 months after onset
Change in Fugyl Meyer score from baseline
Prazo: initial 4 weeks, 3 months after onset
The Fugl-Meyer Assessment for upper extremity (FMA-UE)is considered to assess the body function according to the International Classification of Functioning, Disability and Health (ICF) with a maximum score of 66 points)
initial 4 weeks, 3 months after onset
Change in MMSE-K(Korean Minimental Status Examination)
Prazo: initial 4 weeks,3months after onset
3. The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively to measure cognitive impairment.[1] Higher score indicates better cognitive function.
initial 4 weeks,3months after onset
Change in scores of Quality of Life Survey score (EQ5D(EuroQol-5 dimension)
Prazo: initial 4 weeks, 3months after onset
The QOLS is a reliable and valid instrument for measuring quality of life from the perspective of the patient The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
initial 4 weeks, 3months after onset
Change in Penetration-Aspiration Scale(PAS)
Prazo: 4 weeks, 3 months after onset
initial PAS is a categorical scale that measures level of penetration of bolus(food) into airway at pharynx. It ranges from Score 1 to 8, where 1 indicated no airway entrance of bolus and 8 indicated glottic passage of food. Higher change in PAS indicates improvement in patient's swallowing function.
4 weeks, 3 months after onset
Change in dysphagia outcome rating scale
Prazo: 4 weeks, 3 months after onset
initial The Dysphagia Outcome and Severity Scale (DOSS) is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition with level 1 indicating severe dysphagia and level 7 indicating normal swallowing function.
4 weeks, 3 months after onset
Change in SWAL-QOL(swallowing quality of life)) survey score
Prazo: 4 weeks, 3 months after onset
initial SWAL-QOL is a survey that evaluation patient's subjective quality of life within their swallowing function. Scored will be sumed up where higher score indicates better quality of life.
4 weeks, 3 months after onset
Number of events associated with aspiration pneumonia
Prazo: 4 weeks, 3 months after onset
initial Diagnosis of aspiration pneumonia will be based on ≥3 of the following features: fever (>38°C), productive cough, abnormal respiratory examination, abnormal chest radiograph; specifically involving the dependent portions of the lung; white blood cell count >12,000/mL, or isolation of a relevant pathogen and use of antibiotics)
4 weeks, 3 months after onset

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Catholic University of Korea

Investigadores

  • Diretor de estudo: TaeWoo Kim, National Traffic Rehabilitation Hospital Korea

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de agosto de 2018

Conclusão Primária (Real)

30 de julho de 2019

Conclusão do estudo (Real)

7 de agosto de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de julho de 2018

Primeira postagem (Real)

5 de julho de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de agosto de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de agosto de 2019

Última verificação

1 de julho de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NTRH-18001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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