Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery

Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery

Sponsors

Lead Sponsor: The Catholic University of Korea

Source The Catholic University of Korea
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.

Overall Status Completed
Start Date August 4, 2018
Completion Date August 7, 2019
Primary Completion Date July 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Change in Functional Oral Intake Scale(FOIS) initial 4 weeks,3months after onset
Secondary Outcome
Measure Time Frame
Change in Berg Balance Scale(BBS) initial 4 weeks, 3 months after onset
Change in Medical Research Council(MRC) grade Disability level initial 4 weeks, 3 months after onset
Change in K-MBI(Korean Modified Barthel Index) initial 4 weeks, 3 months after onset
Change in FAC(Functional Ambulatory Category) initial 4 weeks, 3 months after onset
Change in Fugyl Meyer score from baseline initial 4 weeks, 3 months after onset
Change in MMSE-K(Korean Minimental Status Examination) initial 4 weeks,3months after onset
Change in scores of Quality of Life Survey score (EQ5D(EuroQol-5 dimension) initial 4 weeks, 3months after onset
Change in Penetration-Aspiration Scale(PAS) 4 weeks, 3 months after onset
Change in dysphagia outcome rating scale 4 weeks, 3 months after onset
Change in SWAL-QOL(swallowing quality of life)) survey score 4 weeks, 3 months after onset
Number of events associated with aspiration pneumonia 4 weeks, 3 months after onset
Enrollment 220
Condition
Eligibility

Sampling Method: Probability Sample

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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
TaeWoo Kim Study Director National Traffic Rehabilitation Hospital Korea
Location
Facility:
Department of Rehabilitation Medicine | Bucheon, Gyonggido, 14647, Korea, Republic of
Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine | Bucheon, Kyounggido, Korea, Republic of
Location Countries

Korea, Republic of

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The Catholic University of Korea

Investigator Full Name: Sun Im

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Dysphagia patients

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

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov