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

NCT ID: NCT04928079

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2021-07-31

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.

Detailed Description

In baseline, 116 patients with idiopathic PD were recruited from the Neurology Clinic of the Second Affiliated Hospital of Zhejiang University School of Medicine according to the United Kingdom PD Society Brain Bank Clinical Diagnostic Criteria. They were admitted from January 2014 to November 2014, and were followed up after 6 years.

Perform psychiatric and neurological evaluations. And use Videofluoroscopic swallowing study (VFSS) to assess the swallowing function of PD patients. Added 200mg of barium sulfate to 286ml water to achieve a concentration of 60%. Add a thickener (Ourdiet Swallow, Ourdiet Biotech Co. Ltd, Guangzhou, China) to prepare juice and pudding viscosities, No thickener was added to the liquid viscosity. The patients were advised to have boluses of 3, 5 and 10 ml of the liquid, juice, pudding viscosities in sequence according to the clinician's instructions under X-ray fluoroscopy. The patients ware sitting or standing, The lateral view of the patients' swallow was recorded by a camera (30 frames per second). The radiologist, the clinician, and the rehabilitation therapist completed this examination. Two person analyzed the video in slow motion and frame - by - frame, and record abnormal results. The VFSS inspection parameters are Penetration/aspiration score and Residue score. In order to reduce the influence of drugs on dysphagia, all patients were in the off - period. The patients stopped taking anti-Parkinson's disease drugs from 9 o'clock the night before the examination, and were tested in the morning (free of medicine for more than 12 hours).

The patients had completed the above tests in 2014 and were asked to perform the above assessments again.

Conditions

Parkinson Disease; Dysphagia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

deep brain stimulation

performing deep brain stimulation if needed

Intervention Type: PROCEDURE

Anti-Parkinsonian Drugs

Using anti-parkinsonian drugs if needed

Intervention Type: DRUG

Other Intervention Names

DBS; Anti-Parkinsonian medicine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• (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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Luo, PhD

Role: PRINCIPAL_INVESTIGATOR

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

References

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.

Reference Type: RESULT

PMID: 8721066 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26492880 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29948261 (View on PubMed)

Other Identifiers

（2020）LunShenYan（ 191 ）

Identifier Type: -

Identifier Source: org_study_id