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StrokeNCT05989100

Taste Stimulation for Post-stroke Dysphagia

A study testing Favourate taste stimulation, Sour taste stimulation and Thermal stimulation group in people with Stroke and Dysphagia, run by Qilu Hospital of Shandong University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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: 1. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Dysphagia
What is being tested?
Favourate taste stimulation, Sour taste stimulation and Thermal stimulation group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
2 sitesChina
Study dates
1 Sep 2023to 31 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country.

Yonghui Wang, professor contact

86-18560083581

yonghuiwangphd@163.com

China2 sites, 2 recruiting

  • Qilu hospital of Shandong University

    Jinan, Shandong, 250012

    Jie Wang, Ph.D.

    Recruiting

  • Yonghui Wang

    Jinan, Shandong, 250012

    Yonghui Wang, professor, 86-18560083581, yonghuiwangphd@163.com

    Not yet recruiting

Other trials in China

About this study

Official title: 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.
Read more

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.

Read the 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.

Conditions
Stroke, Dysphagia
Being tested
Favourate taste stimulation, Sour taste stimulation, Thermal stimulation group
Keywords
taste stimulation, sour stimulaiton, thermal stimulation, functional near-inrared spectroscopy
Medical subject headings
Stroke, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Favourate taste stimulationBehavioural

    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.

  • Sour taste stimulationBehavioural

    Using sour swab to brush oral cavity and tounge.

  • Thermal stimulation groupBehavioural

    Only ice-water swab to brush oral cavity and tounge.

Study groups in NCT05989100
Study groupRoleWhat they receive
Favourate taste stimulationExperimentalThe 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.
Receives: Behavioral: Favourate taste stimulation
Sour stimulationActive comparatorUsing sour swab to brush oral cavity and tounge of the participant. The treatment duration and other training method is as same as mentioned above.
Receives: Behavioral: Sour taste stimulation
Thermal stimulationPlacebo comparatorOnly ice-water swab to brush oral cavity and tounge. The treatment duration and other training method is as same as mentioned above.
Receives: Behavioral: Thermal stimulation group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Befor and after the three-week treatment, and 3 weeks after the treatment.

Secondary outcomes (3)

  1. 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.

    Measured: Befor and after the three-week treatment, and 3 weeks after the treatment.

  2. FOIS

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

    Measured: Befor and after the three-week treatment, and 3 weeks after the treatment.

  3. 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.

    Measured: Befor and after the three-week treatment, and 3 weeks after the treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Favourate taste stimulation group, sour stimulation group and thermal stimulation group.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05989100
Sponsor's protocol ID
KYLL-202307-024
Status last verified
Aug 2023
First submitted
3 Aug 2023
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35940843

  • 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.

    PubMed 30352222

  • 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.

    PubMed 16362509

Questions about this trial

What is this clinical trial studying?

A study testing Favourate taste stimulation, Sour taste stimulation and Thermal stimulation group in people with Stroke and Dysphagia, run by Qilu Hospital of Shandong University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yonghui Wang, professor (86-18560083581, yonghuiwangphd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hyoid displacement (time frame: Befor and after the three-week treatment, and 3 weeks after the treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05989100, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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