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Status unknownNCT04928079Updated Jun 16, 2021

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

An observational study in Parkinson Disease and Dysphagia, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown. Per ClinicalTrials.gov, last updated 2021-06-16.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
116
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Parkinson Disease
  • Dysphagia

Keywords

  • Parkinson's Disease
  • dysphagia
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In context

Deglutition Disorders

710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.

This study's enrollment of 116 is above the median of 97 across 207 observational studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

116 idiopathic PD

Inclusion criteria

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

Exclusion 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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
116 participants (actual)
Patient registry
No

Interventions

  • Proceduredeep brain stimulation

    performing deep brain stimulation if needed

    Also known as: DBS

  • DrugAnti-Parkinsonian Drugs

    Using anti-parkinsonian drugs if needed

    Also known as: Anti-Parkinsonian medicine

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What researchers measure

Primary outcomes

  1. penetration - aspiration score

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

    Time frame: in the morning, before taking anti-parkinson drugs

  2. 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.

    Time frame: in the morning, before taking anti-parkinson drugs

Secondary outcomes

  1. water swallow test

    The 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.

    Time frame: in the morning, before taking anti-parkinson drugs

  2. SDQ-C

    The Chinese version of the Swallowing Disturbance Questionnaire

    Time frame: in the morning, before taking anti-parkinson drugs

Other outcomes

  1. MMSE

    Mini-mental State Examination (MMSE);

    Time frame: in the morning, before taking anti-parkinson drugs

  2. HAMD

    Hamilton Depression Scale

    Time frame: in the morning, before taking anti-parkinson drugs

  3. HAMA

    Hamilton Anxiety Scale

    Time frame: in the morning, before taking anti-parkinson drugs

  4. H&Y

    Hoehn-Yahr stage

    Time frame: in the morning, before taking anti-parkinson drugs

  5. PDQ-39

    Parkinson Disease Quality of Life Measure

    Time frame: in the morning, before taking anti-parkinson drugs

  6. NMSQ

    Non-Motor Symptoms Quest

    Time frame: in the morning, before taking anti-parkinson drugs

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 8721066 ↗
  • 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. PubMed 26492880 ↗
  • 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. PubMed 29948261 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04928079
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jun 16, 2021
Start date
Jan 1, 2014
Primary completion
Jul 31, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Jun 16, 2021

Study contacts

Wei Luo, PhD
principal investigator · the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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