- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577444
Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gyonggido
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Bucheon, Gyonggido, Korea, Republic of, 14647
- Department of Rehabilitation Medicine
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Kyounggido
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Bucheon, Kyounggido, Korea, Republic of
- Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Functional Oral Intake Scale(FOIS)
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Berg Balance Scale(BBS)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Study Director: TaeWoo Kim, National Traffic Rehabilitation Hospital Korea
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTRH-18001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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