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Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery

6 agosto 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

220

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

  • Corea, Repubblica di
    • Gyonggido
      • Bucheon, Gyonggido, Corea, Repubblica di, 14647
        • Department of Rehabilitation Medicine
    • Kyounggido
      • Bucheon, Kyounggido, Corea, Repubblica di
        • Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine

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

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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

Descrizione

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.

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Functional Oral Intake Scale(FOIS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Berg Balance Scale(BBS)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

The Catholic University of Korea

Investigatori

  • Direttore dello studio: TaeWoo Kim, National Traffic Rehabilitation Hospital Korea

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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)

4 agosto 2018

Completamento primario (Effettivo)

30 luglio 2019

Completamento dello studio (Effettivo)

7 agosto 2019

Date di iscrizione allo studio

Primo inviato

8 giugno 2018

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2018

Primo Inserito (Effettivo)

5 luglio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2019

Ultimo verificato

1 luglio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NTRH-18001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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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