Taste Stimulation for Post-stroke Dysphagia

November 30, 2023 updated by: Qilu Hospital of Shandong University

Effects of Taste Stimulation on Swallowing Function of Patient With Post-stroke Dysphagia and Its Mechanism

The goal of this clinical study is to compare the effect of favourate taste stimulation of oral cavity and tounge, with sour and traditional single thermal stimulation in post-stroke patients with dysphagia. The main questions it aims to answer are:

  1. Whether favourate taste stimulation of oral and tounge is better than traditional thermal stimulation in improving swallowing function of patients with dysphagia.
  2. It has been reported that taste of sour stimulation can increase the frequency of swallowing. In this study, we want to know which is better for improving swallowing function between favourate taste stimulation and sour taste stimulation.
  3. Functional near-infrared spectroscopy (fNIRS) will be applied in this study to understand the neural mechanism of taste stimulation in improving swallowing function.

Participants screened as post-stroke dysphagia will accept swallowing evaluation and fNIRS test before and after treatment. The treatment include taste stimulation and traditional swallowing training.

Researchers will compare favourate taste stimulation with sour-taste stimulation and single thermal stimulation to see if the swallowing function improved faster and better in favourate taste stimulation group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Taste perception can help to initiate swallow. Different taste has different impact on swallowing function. Patients with post-stroke dysphagia always have taste impairment and initiation delay of swallowing. In this study, patients with dysphagia after stroke will be recruited and treated with favourate taste stimulation or sour taste stimulation or non-taste stimulation for 2 weeks. Traditional swallowing rehabilitation will be applied base on the status of patients. Before and after the treatment, participants completed swallowing assessment, including quantitative measurement of hyoid displacement, functional oral intake scale (FOIS), dysphagia severity rating scale (DSRS), and standardized swallowing assessment (SSA). In order to understand the effect of taste stimulation on brain network, fNIRS will be conducted.The participants have to conduct these examination three to four weeks after the treatment to undertand the long-time effect of taste stimulation.

Study Type

Interventional

Enrollment (Estimated)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital Of Shandong University
        • Contact:
          • Jie Wang, Ph.D.
      • Jinan, Shandong, China, 250012
        • Not yet recruiting
        • Yonghui Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. diagnosed as first-ever stroke and diagnosed as dysphagia with modified water swallowing test, duration of dysphagia was more than one month;
  2. can complete all the test with MMSE >15;
  3. agree to participate the experiment, and sign the written informed consent.

Exclusion Criteria:

  1. have other diseases that could induce dysphagia, such as cranial and neck tumor, history of radiotherapy or chemotherapy, tongue muscle atrophy, myasthenia gravis, parotid tumor and multiple sclerosis, etc;
  2. lose of taste perception;
  3. combined with other major disease that can not tolerate the examination and swallowing training;
  4. surgery of cranial allogeneic plasticity, scalp ulcer or damage that thought as contraindications of fNIRS.
  5. with other neurological conditions (eg, Parkinson's disease, dementia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sour stimulation
Using sour swab to brush oral cavity and tounge of the participant. The treatment duration and other training method is as same as mentioned above.
Behavioral: Sour taste stimulation
Using sour swab to brush oral cavity and tounge.
Placebo Comparator: Thermal stimulation
Only ice-water swab to brush oral cavity and tounge. The treatment duration and other training method is as same as mentioned above.
Behavioral: Thermal stimulation group
Only ice-water swab to brush oral cavity and tounge.
Experimental: Favourate taste stimulation
The swab will be immersed in sugar, salt, citric acid, or paprika mixed with water, and be placed in -18℃ refrigerator. Select the swabs of the participant favourate taste to brush oral cavity and tounge. The stimulation will last two to three minutes one time, and twice for a rehabilitation session, once per day and six days every week, three weeks totally. Swallowing rehabilitation also include standard training that carried out in the department.
Behavioral: Favourate taste stimulation
The taste stimulaiton for swallowing is completed with long swab. Taste solution will be prepared with sugar, salt, citric acid, or paprika mixed with water. And the swab will be immersed in the solution and freezed in -18℃ circumstances. Bilateral buccal mucosa，palate and tounge will be brushed. Four swabs will be used in a training session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyoid displacement
Time Frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
The probe of ultrosound will be placed in the middle of the neck, paralled to the sagittal line. Record the video of participant drinking 1ml water, the distance between hyoid and chin at rest minus distance during hyoid and chin are nerest. Repeated three times, and the mean value is further into analysis.
Befor and after the three-week treatment, and 3 weeks after the treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SSA
Time Frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
Standardized swallowing assessment (SSA) include clinical examination, drinking 5mL water test and drinking 60mL water test.lowest score is 18, and the highest score is 46, high score indicationg poor condition.
Befor and after the three-week treatment, and 3 weeks after the treatment.
FOIS
Time Frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
Functional oral intake scale. From one to seven, high score indicate better oral intake function.
Befor and after the three-week treatment, and 3 weeks after the treatment.
DSRS
Time Frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
The Dysphagia Severity Rating Scale (DSRS) assigns a score to the feeding status achieved by the dysphagic patient depending on the categories of feeding stage for fluid and dietary consumption in addition to the level of dependency required for feeding. The score for each category can vary between 0 and 4 points, and is added to give a composite score. These scores were calculated by a speech and language therapist with special interest in neurogenic dysphagia. SALT：speech and language therapist.
Befor and after the three-week treatment, and 3 weeks after the treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
fNIRS
Time Frame: Befor and after the three-week treatment, and 3 weeks after the treatment.
Functional near-infrared spectroscopy (fNIRS) is a tool for measuring the HbO2 concentration to reflect the excitation of cortex. Further analysis can help to explain the network of the brain.
Befor and after the three-week treatment, and 3 weeks after the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Shandong University

Investigators

  • Principal Investigator: Yonghui Wang, professor, Qilu Hospital Of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202307-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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