Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery
6 augusti 2019 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
220
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Gyonggido
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Bucheon, Gyonggido, Korea, Republiken av, 14647
- Department of Rehabilitation Medicine
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Kyounggido
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Bucheon, Kyounggido, Korea, Republiken av
- Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
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
Beskrivning
Inclusion Criteria
- 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)
- Patients who were hospitalized for 30 days and were followed up at 3 months after the onset of brain lesions
- 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.
- 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
- Patients who do not meet the above criteria
- Patients with difficulty in collecting blood for genetic testing
- Patients who were not able to followed-up for 6 months(follow up loss patients)
- Patients with long-term Parkinson's disease, Alzheimer's disease, Guillain-Barre syndrome, myasthenia gravis syndrome, etc.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Dysphagia patients
Patients who had been diagnosed with neurogenic dysphagia related to either stroke or traumatic brain injury at two university affiliated hospitals
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in Functional Oral Intake Scale(FOIS)
Tidsram: initial 4 weeks,3months after onset
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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.
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initial 4 weeks,3months after onset
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Berg Balance Scale(BBS)
Tidsram: initial 4 weeks, 3 months after onset
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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.
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initial 4 weeks, 3 months after onset
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Change in Medical Research Council(MRC) grade Disability level
Tidsram: initial 4 weeks, 3 months after onset
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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
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Change in K-MBI(Korean Modified Barthel Index)
Tidsram: initial 4 weeks, 3 months after onset
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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.
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initial 4 weeks, 3 months after onset
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Change in FAC(Functional Ambulatory Category)
Tidsram: initial 4 weeks, 3 months after onset
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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.
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initial 4 weeks, 3 months after onset
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Change in Fugyl Meyer score from baseline
Tidsram: initial 4 weeks, 3 months after onset
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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)
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initial 4 weeks, 3 months after onset
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Change in MMSE-K(Korean Minimental Status Examination)
Tidsram: initial 4 weeks,3months after onset
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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.
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initial 4 weeks,3months after onset
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Change in scores of Quality of Life Survey score (EQ5D(EuroQol-5 dimension)
Tidsram: initial 4 weeks, 3months after onset
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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.
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initial 4 weeks, 3months after onset
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Change in Penetration-Aspiration Scale(PAS)
Tidsram: 4 weeks, 3 months after onset
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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.
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4 weeks, 3 months after onset
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Change in dysphagia outcome rating scale
Tidsram: 4 weeks, 3 months after onset
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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.
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4 weeks, 3 months after onset
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Change in SWAL-QOL(swallowing quality of life)) survey score
Tidsram: 4 weeks, 3 months after onset
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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.
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4 weeks, 3 months after onset
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Number of events associated with aspiration pneumonia
Tidsram: 4 weeks, 3 months after onset
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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)
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4 weeks, 3 months after onset
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: TaeWoo Kim, National Traffic Rehabilitation Hospital Korea
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Park HY, Kim Y, Oh HM, Kim TW, Park GY, Im S. Potential Prognostic Impact of Dopamine Receptor D1 (rs4532) Polymorphism in Post-stroke Outcome in the Elderly. Front Neurol. 2021 Jun 30;12:675060. doi: 10.3389/fneur.2021.675060. eCollection 2021.
- Oh HM, Kim TW, Park HY, Kim Y, Park GY, Im S. Role of rs6265 BDNF polymorphisms and post-stroke dysphagia recovery-A prospective cohort study. Neurogastroenterol Motil. 2021 Jan;33(1):e13953. doi: 10.1111/nmo.13953. Epub 2020 Aug 9.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 augusti 2018
Primärt slutförande (Faktisk)
30 juli 2019
Avslutad studie (Faktisk)
7 augusti 2019
Studieregistreringsdatum
Först inskickad
8 juni 2018
Först inskickad som uppfyllde QC-kriterierna
3 juli 2018
Första postat (Faktisk)
5 juli 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 augusti 2019
Senast verifierad
1 juli 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NTRH-18001
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