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Taste Stimulation for Post-stroke Dysphagia

Primary Purpose

Stroke, Dysphagia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Favourate taste stimulation
Sour taste stimulation
Thermal stimulation group
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring taste stimulation, sour stimulaiton, thermal stimulation, functional near-inrared spectroscopy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosed as first-ever stroke and diagnosed as dysphagia with modified water swallowing test, duration of dysphagia was more than one month; can complete all the test with MMSE >15; agree to participate the experiment, and sign the written informed consent. Exclusion Criteria: 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; lose of taste perception; combined with other major disease that can not tolerate the examination and swallowing training; surgery of cranial allogeneic plasticity, scalp ulcer or damage that thought as contraindications of fNIRS. with other neurological conditions (eg, Parkinson's disease, dementia).

Sites / Locations

  • Yonghui Wang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Favourate taste stimulation

Sour stimulation

Thermal stimulation

Arm Description

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.

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.

Only ice-water swab to brush oral cavity and tounge. The treatment duration and other training method is as same as mentioned above.

Outcomes

Primary Outcome Measures

Hyoid displacement
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.

Secondary Outcome Measures

SSA
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.
FOIS
Functional oral intake scale. From one to seven, high score indicate better oral intake function.
DSRS
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.

Full Information

First Posted
August 3, 2023
Last Updated
September 18, 2023
Sponsor
Qilu Hospital of Shandong University
Collaborators
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05989100
Brief Title
Taste Stimulation for Post-stroke Dysphagia
Official Title
Effects of Taste Stimulation on Swallowing Function of Patient With Post-stroke Dysphagia and Its Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University
Collaborators
Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: Whether favourate taste stimulation of oral and tounge is better than traditional thermal stimulation in improving swallowing function of patients with dysphagia. 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia
Keywords
taste stimulation, sour stimulaiton, thermal stimulation, functional near-inrared spectroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Favourate taste stimulation group, sour stimulation group and thermal stimulation group.
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Favourate taste stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sour stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Thermal stimulation
Arm Type
Placebo Comparator
Arm Description
Only ice-water swab to brush oral cavity and tounge. The treatment duration and other training method is as same as mentioned above.
Intervention Type
Behavioral
Intervention Name(s)
Favourate taste stimulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sour taste stimulation
Intervention Description
Using sour swab to brush oral cavity and tounge.
Intervention Type
Behavioral
Intervention Name(s)
Thermal stimulation group
Intervention Description
Only ice-water swab to brush oral cavity and tounge.
Primary Outcome Measure Information:
Title
Hyoid displacement
Description
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.
Time Frame
Befor and after the three-week treatment, and 3 weeks after the treatment.
Secondary Outcome Measure Information:
Title
SSA
Description
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.
Time Frame
Befor and after the three-week treatment, and 3 weeks after the treatment.
Title
FOIS
Description
Functional oral intake scale. From one to seven, high score indicate better oral intake function.
Time Frame
Befor and after the three-week treatment, and 3 weeks after the treatment.
Title
DSRS
Description
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.
Time Frame
Befor and after the three-week treatment, and 3 weeks after the treatment.
Other Pre-specified Outcome Measures:
Title
fNIRS
Description
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.
Time Frame
Befor and after the three-week treatment, and 3 weeks after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed as first-ever stroke and diagnosed as dysphagia with modified water swallowing test, duration of dysphagia was more than one month; can complete all the test with MMSE >15; agree to participate the experiment, and sign the written informed consent. Exclusion Criteria: 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; lose of taste perception; combined with other major disease that can not tolerate the examination and swallowing training; surgery of cranial allogeneic plasticity, scalp ulcer or damage that thought as contraindications of fNIRS. with other neurological conditions (eg, Parkinson's disease, dementia).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonghui Wang, professor
Phone
86-18560083581
Email
yonghuiwangphd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonghui Wang, professor
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonghui Wang
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghui Wang, professor
Phone
86-18560083581
Email
yonghuiwangphd@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35940843
Citation
Nowrin I, Bhattacharyya DS, Saif-Ur-Rahman KM. Community-based interventions to prevent stroke in low-income and middle-income countries: a protocol for a systematic review and meta-analysis. BMJ Open. 2022 Aug 8;12(8):e063181. doi: 10.1136/bmjopen-2022-063181.
Results Reference
background
PubMed Identifier
30352222
Citation
Chiang CF, Lin MT, Hsiao MY, Yeh YC, Liang YC, Wang TG. Comparative Efficacy of Noninvasive Neurostimulation Therapies for Acute and Subacute Poststroke Dysphagia: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):739-750.e4. doi: 10.1016/j.apmr.2018.09.117. Epub 2018 Oct 21.
Results Reference
background
PubMed Identifier
16362509
Citation
Palmer PM, McCulloch TM, Jaffe D, Neel AT. Effects of a sour bolus on the intramuscular electromyographic (EMG) activity of muscles in the submental region. Dysphagia. 2005 Summer;20(3):210-7. doi: 10.1007/s00455-005-0017-x.
Results Reference
background

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Taste Stimulation for Post-stroke Dysphagia

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