Clinical trial NCT03577444: Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery
Official title: Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Dysphagia
Keywords: gene polymorphism
stroke
dysphagia
poststroke recovery
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Functional Oral Intake Scale(FOIS)
timeFrame: initial 4 weeks,3months after onset
Secondary outcomes:
measure: Change in Berg Balance Scale(BBS)
timeFrame: initial 4 weeks, 3 months after onset
measure: Change in Medical Research Council(MRC) grade Disability level
timeFrame: initial 4 weeks, 3 months after onset
measure: Change in K-MBI(Korean Modified Barthel Index)
timeFrame: initial 4 weeks, 3 months after onset
measure: Change in FAC(Functional Ambulatory Category)
timeFrame: initial 4 weeks, 3 months after onset
measure: Change in Fugyl Meyer score from baseline
timeFrame: initial 4 weeks, 3 months after onset
measure: Change in MMSE-K(Korean Minimental Status Examination)
timeFrame: initial 4 weeks,3months after onset
measure: Change in scores of Quality of Life Survey score (EQ5D(EuroQol-5 dimension)
timeFrame: initial 4 weeks, 3months after onset
measure: Change in Penetration-Aspiration Scale(PAS)
timeFrame: 4 weeks, 3 months after onset
measure: Change in dysphagia outcome rating scale
timeFrame: 4 weeks, 3 months after onset
measure: Change in SWAL-QOL(swallowing quality of life)) survey score
timeFrame: 4 weeks, 3 months after onset
measure: Number of events associated with aspiration pneumonia
timeFrame: 4 weeks, 3 months after onset
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Department of Rehabilitation Medicine
state: Gyonggido
city: Bucheon
country: Korea, Republic of
facility: Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
state: Kyounggido
Study officials:
affiliation: National Traffic Rehabilitation Hospital Korea
name: TaeWoo Kim
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.