Taste Stimulation for Post-stroke Dysphagia

NCT ID: NCT05989100

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Dysphagia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

taste stimulation sour stimulaiton thermal stimulation functional near-inrared spectroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Favourate taste stimulation group, sour stimulation group and thermal stimulation group.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Favourate taste stimulation

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

Sour taste stimulation

Intervention Type BEHAVIORAL

Using sour swab to brush oral cavity and tounge.

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.

Group Type PLACEBO_COMPARATOR

Thermal stimulation group

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Sour taste stimulation

Using sour swab to brush oral cavity and tounge.

Intervention Type BEHAVIORAL

Thermal stimulation group

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong University

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yonghui Wang, professor

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Yonghui Wang

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yonghui Wang, professor

Role: CONTACT

Phone: 86-18560083581

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jie Wang, Ph.D.

Role: primary

Yonghui Wang, professor

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 35940843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30352222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16362509 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KYLL-202307-024

Identifier Type: -

Identifier Source: org_study_id