NCT05989100

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:

  1. 1.Whether favourate taste stimulation of oral and tounge is better than traditional thermal stimulation in improving swallowing function of patients with dysphagia.
  2. 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. 3.Functional near-infrared spectroscopy (fNIRS) will be applied in this study to understand the neural mechanism of taste stimulation in improving swallowing function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

December 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

August 3, 2023

Last Update Submit

November 30, 2023

Conditions

StrokeDysphagia

Keywords

taste stimulationsour stimulaitonthermal stimulationfunctional near-inrared spectroscopy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

  • SSA

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

  • FOIS

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

  • DSRS

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

Other Outcomes (1)

  • fNIRS

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

Study Arms (3)

Favourate taste stimulation

EXPERIMENTAL

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

Sour stimulation

ACTIVE COMPARATOR

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

Thermal stimulation

PLACEBO COMPARATOR

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

Interventions

Favourate taste stimulationBEHAVIORAL

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.

Favourate taste stimulation
Sour taste stimulationBEHAVIORAL

Using sour swab to brush oral cavity and tounge.

Sour stimulation
Thermal stimulation groupBEHAVIORAL

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

Thermal stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Yonghui Wang

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Related Publications (3)

  • 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.

    PMID: 35940843BACKGROUND

  • 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.

    PMID: 30352222BACKGROUND

  • 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.

    PMID: 16362509BACKGROUND

MeSH Terms

Conditions

StrokeDeglutition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Yonghui Wang, professor

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghui Wang, professor

CONTACT

86-18560083581yonghuiwangphd@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Favourate taste stimulation group, sour stimulation group and thermal stimulation group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

January 31, 2025

Study Completion

July 31, 2025

Last Updated

December 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)