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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04928079
• Other study ID #: (2020)LunShenYan( 191 )
• Status: Enrolling by invitation
• Start date: January 1, 2014
• Est. completion date: July 31, 2021

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 116
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Parkinson Disease

Intervention

Procedure:
• deep brain stimulation
performing deep brain stimulation if needed

Drug:
• Anti-Parkinsonian Drugs
Using anti-parkinsonian drugs if needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

References & Publications (3)

Argolo N, Sampaio M, Pinho P, Melo A, Nóbrega 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. — View 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 — View Citation

Rosenbek JC, Robbins JA, Roecker EB, Coyle JL, Wood JL. A penetration-aspiration scale. Dysphagia. 1996 Spring;11(2):93-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MMSE	Mini-mental State Examination (MMSE);	in the morning, before taking anti-parkinson drugs
Other	HAMD	Hamilton Depression Scale	in the morning, before taking anti-parkinson drugs
Other	HAMA	Hamilton Anxiety Scale	in the morning, before taking anti-parkinson drugs
Other	H&Y	Hoehn-Yahr stage	in the morning, before taking anti-parkinson drugs
Other	PDQ-39	Parkinson Disease Quality of Life Measure	in the morning, before taking anti-parkinson drugs
Other	NMSQ	Non-Motor Symptoms Quest	in the morning, before taking anti-parkinson drugs
Primary	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
Primary	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	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 pro?le and episodes are monitored and assessed.	in the morning, before taking anti-parkinson drugs
Secondary	SDQ-C	The Chinese version of the Swallowing Disturbance Questionnaire	in the morning, before taking anti-parkinson drugs