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Clinical Trials/NCT03577444
NCT03577444
Completed
Not Applicable

Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery

The Catholic University of Korea2 sites in 1 country220 target enrollmentAugust 4, 2018
ConditionsStrokeDysphagia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
The Catholic University of Korea
Enrollment
220
Locations
2
Primary Endpoint
Change in Functional Oral Intake Scale(FOIS)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 4, 2018
End Date
August 7, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sun Im

Associate Professor

The Catholic University of Korea

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 scores of Quality of Life Survey score (EQ5D(EuroQol-5 dimension)(initial 4 weeks, 3months after onset)
  • Change in Fugyl Meyer score from baseline(initial 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)
  • 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 MMSE-K(Korean Minimental Status Examination)(initial 4 weeks,3months after onset)
  • Change in Penetration-Aspiration Scale(PAS)(4 weeks, 3 months after onset)
  • Number of events associated with aspiration pneumonia(4 weeks, 3 months after onset)

Study Sites (2)

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