6-year Follow-up of Dysphagia in Patients With Parkinson's Disease

NCT04928079 | Unknown

• 1 other identifier: （2020）LunShenYan（ 191 ）
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

We recruited 116 patients with idiopathic PD who were from the Neurology clinic of the Second Affiliated Hospital of Zhejiang University, School of Medicine from January 2014 to November 2014. Perform videofluroscopic swallowing study and psychiatric and neurological evaluations and followed up after 6 years.

Conditions

Parkinson Disease; Dysphagia

Keywords

Parkinson's Disease; dysphagia

Outcome Measures

Primary Outcomes (2)

• penetration - aspiration score

  according to the 8-Point Penetration-Aspiration Scale, PAS ≥ 6 means that material enters below the vocal cords.

  in the morning, before taking anti-parkinson drugs

• residue score

  evaluate the residue in the oral cavity and pharynx (vallecula, pyriform sinuses) after the first swallowing. Residue amount was rated on a scale from 0 to 3: no residue visible, 0 score; mild residue (less than 25% of the level of the height of the structure), 1 score; moderate residue (25% to 50% of the height of the structure), 2 score; severe residue (high than 50% of the structure height), 3 score.

  in the morning, before taking anti-parkinson drugs

Secondary Outcomes (2)

• water swallow test

  in the morning, before taking anti-parkinson drugs

• SDQ-C

  in the morning, before taking anti-parkinson drugs

Other Outcomes (6)

• MMSE

  in the morning, before taking anti-parkinson drugs

• HAMD

  in the morning, before taking anti-parkinson drugs

• HAMA

  in the morning, before taking anti-parkinson drugs

Interventions

deep brain stimulation PROCEDURE

performing deep brain stimulation if needed

Also known as: DBS

Anti-Parkinsonian Drugs DRUG

Using anti-parkinsonian drugs if needed

Also known as: Anti-Parkinsonian medicine

Eligibility Criteria

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

Study Population

116 idiopathic PD

You may qualify if:

• idiopathic PD according to the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria.

You may not qualify if:

• (1) Parkinsonian syndromes;(2) with severe lung disease, severe liver insufficiency and cardiac insufficiency; (3) Kubota water drinking test grade ≥3; (4) have had or combined other diseases that affect swallowing function; (5) Nasal feeding, gastric reflux or gastrostomy; (6) Mental disorders Or patients with low intelligence and cognitive function, unable to understand and cooperate with the examination.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Related Publications (3)

• Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. doi: 10.1007/BF00417897.

  PMID: 8721066 RESULT

• Argolo N, Sampaio M, Pinho P, Melo A, Nobrega AC. Videofluoroscopic Predictors of Penetration-Aspiration in Parkinson's Disease Patients. Dysphagia. 2015 Dec;30(6):751-8. doi: 10.1007/s00455-015-9653-y. Epub 2015 Oct 22.

  PMID: 26492880 RESULT

• Fukuoka T, Ono T, Hori K, Wada Y, Uchiyama Y, Kasama S, Yoshikawa H, Domen K. Tongue Pressure Measurement and Videofluoroscopic Study of Swallowing in Patients with Parkinson's Disease. Dysphagia. 2019 Feb;34(1):80-88. doi: 10.1007/s00455-018-9916-5. Epub 2018 Jun 8.

  PMID: 29948261 RESULT

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Wei Luo, PhD

  the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: January 1, 2014
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share