Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery

NCT03577444 | Completed DMC

• 1 other identifier: NTRH-18001
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Dysphagia

Keywords

gene polymorphism; stroke; dysphagia; poststroke recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  initial 4 weeks,3months after onset

Secondary Outcomes (11)

• 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

Study Arms (1)

Dysphagia patients

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (2)

Department of Rehabilitation Medicine

Bucheon-si, Gyonggido, 14647, South Korea

Location

Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine

Bucheon-si, Kyounggido, South Korea

Location

Related Publications (2)

• 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.

  PMID: 34276537 DERIVED

• 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.

  PMID: 32776402 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum analysis

MeSH Terms

Conditions

Stroke; Deglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• TaeWoo Kim

  National Traffic Rehabilitation Hospital Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 5, 2018
• Study Start: August 4, 2018
• Primary Completion: July 30, 2019
• Study Completion: August 7, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)