Clinical trial NCT04928079: 6-year Follow-up of Dysphagia in Patients With Parkinson's Disease
Official title: 6-year Follow-up of Dysphagia in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Dysphagia
Keywords: Parkinson's Disease
dysphagia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 116 idiopathic PD

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.

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.

Primary outcomes:
measure: penetration - aspiration score
timeFrame: in the morning, before taking anti-parkinson drugs
measure: residue score
timeFrame: in the morning, before taking anti-parkinson drugs
Secondary outcomes:
measure: water swallow test
timeFrame: in the morning, before taking anti-parkinson drugs
measure: SDQ-C
timeFrame: in the morning, before taking anti-parkinson drugs
Other outcomes:
measure: MMSE
timeFrame: in the morning, before taking anti-parkinson drugs
measure: HAMD
timeFrame: in the morning, before taking anti-parkinson drugs
measure: HAMA
timeFrame: in the morning, before taking anti-parkinson drugs
measure: H&Y
timeFrame: in the morning, before taking anti-parkinson drugs
measure: PDQ-39
timeFrame: in the morning, before taking anti-parkinson drugs
measure: NMSQ
timeFrame: in the morning, before taking anti-parkinson drugs
Locations:
Study officials:
affiliation: the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
name: Wei Luo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.