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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04928079
Enrollment
116
Registered
2021-06-16
Start date
2014-01-01
Completion date
2021-07-31
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Parkinson Disease

Keywords

Parkinson's Disease, dysphagia

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.

Interventions

PROCEDUREdeep brain stimulation

performing deep brain stimulation if needed

DRUGAnti-Parkinsonian Drugs

Using anti-parkinsonian drugs if needed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
penetration - aspiration scorein the morning, before taking anti-parkinson drugsaccording to the 8-Point Penetration-Aspiration Scale, PAS ≥ 6 means that material enters below the vocal cords.
residue scorein the morning, before taking anti-parkinson drugsevaluate 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.

Secondary

MeasureTime frameDescription
water swallow testin the morning, before taking anti-parkinson drugsThe patient is asked to sit in a chair, and is handed a cup containing 30 mL of water at normal temperature. The patient is then asked to Please drink this water as you usually do. Time to empty a cup is measured, and the drinking profile and episodes are monitored and assessed.
SDQ-Cin the morning, before taking anti-parkinson drugsThe Chinese version of the Swallowing Disturbance Questionnaire

Other

MeasureTime frameDescription
PDQ-39in the morning, before taking anti-parkinson drugsParkinson Disease Quality of Life Measure
MMSEin the morning, before taking anti-parkinson drugsMini-mental State Examination (MMSE);
NMSQin the morning, before taking anti-parkinson drugsNon-Motor Symptoms Quest
HAMDin the morning, before taking anti-parkinson drugsHamilton Depression Scale
HAMAin the morning, before taking anti-parkinson drugsHamilton Anxiety Scale
H&Yin the morning, before taking anti-parkinson drugsHoehn-Yahr stage

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026