StrokeNCT03577444
Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery
An observational study of Stroke and Dysphagia, run by The Catholic University of Korea at 2 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- How many people
- 220 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 4 Aug 2018to 7 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Department of Rehabilitation Medicine
Bucheon-si, Gyonggido, 14647
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
Bucheon-si, Kyounggido
About this study
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.
Read the 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.
- Keywords
- gene polymorphism, stroke, dysphagia, poststroke recovery
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia patients | Patients who had been diagnosed with neurogenic dysphagia related to either stroke or traumatic brain injury at two university affiliated hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Oral Intake Scale(FOIS)
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.
Measured: initial 4 weeks,3months after onset
Secondary outcomes (11)
Change in Berg Balance Scale(BBS)
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.
Measured: initial 4 weeks, 3 months after onset
Change in Medical Research Council(MRC) grade Disability level
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.
Measured: initial 4 weeks, 3 months after onset
Change in K-MBI(Korean Modified Barthel Index)
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.
Measured: initial 4 weeks, 3 months after onset
Change in FAC(Functional Ambulatory Category)
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.
Measured: initial 4 weeks, 3 months after onset
Change in Fugyl Meyer score from baseline
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)
Measured: initial 4 weeks, 3 months after onset
Change in MMSE-K(Korean Minimental Status Examination)
- 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.
Measured: initial 4 weeks,3months after onset
Change in scores of Quality of Life Survey score (EQ5D(EuroQol-5 dimension)
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.
Measured: initial 4 weeks, 3months after onset
Change in Penetration-Aspiration Scale(PAS)
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.
Measured: 4 weeks, 3 months after onset
Change in dysphagia outcome rating scale
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.
Measured: 4 weeks, 3 months after onset
Change in SWAL-QOL(swallowing quality of life)) survey score
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.
Measured: 4 weeks, 3 months after onset
Number of events associated with aspiration pneumonia
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)
Measured: 4 weeks, 3 months after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start4 Aug 2018
- Primary completion30 Jul 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- TaeWoo Kim, Study director, National Traffic Rehabilitation Hospital Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577444
- Sponsor's protocol ID
- NTRH-18001
- Status last verified
- Jul 2019
- First submitted
- 8 Jun 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34276537Oh 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.
PubMed 32776402
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery
- ClinicalTrials.gov ID
- NCT03577444
- Acronym / sponsor ID
- NTRH-18001
- Keywords
- gene polymorphism, stroke, dysphagia, poststroke recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 4 Aug 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysphagia patients | – | –Patients who had been diagnosed with neurogenic dysphagia related to either stroke or traumatic brain injury at two university affiliated hospitals |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Functional Oral Intake Scale(FOIS)
Time frame: 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.
11 secondary outcomes
Change in Berg Balance Scale(BBS)
Time frame: initial 4 weeks, 3 months after onset
Change in Medical Research Council(MRC) grade Disability level
Time frame: initial 4 weeks, 3 months after onset
Change in K-MBI(Korean Modified Barthel Index)
Time frame: initial 4 weeks, 3 months after onset
Change in FAC(Functional Ambulatory Category)
Time frame: initial 4 weeks, 3 months after onset
Change in Fugyl Meyer score from baseline
Time frame: initial 4 weeks, 3 months after onset
Change in MMSE-K(Korean Minimental Status Examination)
Time frame: initial 4 weeks,3months after onset
Change in scores of Quality of Life Survey score (EQ5D(EuroQol-5 dimension)
Time frame: initial 4 weeks, 3months after onset
Change in Penetration-Aspiration Scale(PAS)
Time frame: 4 weeks, 3 months after onset
Change in dysphagia outcome rating scale
Time frame: 4 weeks, 3 months after onset
Change in SWAL-QOL(swallowing quality of life)) survey score
Time frame: 4 weeks, 3 months after onset
Number of events associated with aspiration pneumonia
Time frame: 4 weeks, 3 months after onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 34276537Park 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.
- Derived from this study: PubMed 32776402Oh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TaeWoo Kim study director
National Traffic Rehabilitation Hospital Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Dysphagia, run by The Catholic University of Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Oral Intake Scale(FOIS) (time frame: initial 4 weeks,3months after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577444, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.