Clinical trial NCT05989100: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Dysphagia
Keywords: taste stimulation
sour stimulaiton
thermal stimulation
functional near-inrared spectroscopy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong University
First posted: 2023-08-14
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Favourate taste stimulation group, sour stimulation group and thermal stimulation group.
Primary purpose: TREATMENT

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. 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Hyoid displacement
timeFrame: Befor and after the three-week treatment, and 3 weeks after the treatment.
Secondary outcomes:
measure: SSA
timeFrame: Befor and after the three-week treatment, and 3 weeks after the treatment.
measure: FOIS
timeFrame: Befor and after the three-week treatment, and 3 weeks after the treatment.
measure: DSRS
timeFrame: Befor and after the three-week treatment, and 3 weeks after the treatment.
Other outcomes:
measure: fNIRS
timeFrame: Befor and after the three-week treatment, and 3 weeks after the treatment.
Locations:
city: Jinan
country: China
facility: Qilu hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Yonghui Wang
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yonghui Wang, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.