Dysphagia
Conditions
Brief summary
This randomized, double-blind, sham-controlled clinical trial will investigate the effects and potential neural mechanisms of pharyngeal air-pulse sensory stimulation in patients with post-stroke dysphagia. A total of 80 participants with swallowing impairment after stroke will be randomly assigned in a 1:1 ratio to either an active stimulation group or a sham stimulation group. Both groups will receive conventional swallowing rehabilitation, while the active group will additionally receive pharyngeal air-pulse sensory stimulation and the control group will receive sham stimulation for 2 weeks. Swallowing function and neurophysiological changes will be assessed before and after the intervention. Assessments will include clinical swallowing evaluations, videofluoroscopic swallowing study, surface electromyography, resting-state and task-based functional magnetic resonance imaging, and diffusion kurtosis imaging. The study aims to determine whether pharyngeal air-pulse sensory stimulation can improve swallowing function and to explore associated changes in swallowing-related sensory-motor brain networks after stroke.
Interventions
DEVICEAir-Pulse Sensory Stimulation
Active pharyngeal air-pulse sensory stimulation is delivered using a pharyngeal air-pulse sensory stimulation device. The stimulation site is the anterior wall of the piriform sinus or the aryepiglottic fold. Air-pulse stimulation is delivered at a frequency of 48 pulses per minute, with 1 minute of stimulation alternating with 1 minute of rest, for a total session duration of 20 minutes and approximately 480 air pulses per session.
DEVICEsham intervention
Sham pharyngeal air-pulse sensory stimulation is delivered using the same device. The catheter insertion procedure, placement method, and duration are kept consistent with those used in the active stimulation group to maintain blinding.
Sponsors
First People's Hospital of Foshan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
Yes
Inclusion criteria
1. Diagnosis of stroke according to the Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases. 2. Dysphagia confirmed by videofluoroscopic swallowing study (VFSS) or fiberoptic endoscopic evaluation of swallowing (FEES). 3. Functional Oral Intake Scale (FOIS) score of 1-5. 4. Stable vital signs. 5. Time since stroke onset of at least 1 month. 6. Age 18-76 years. 7. No severe impairment of auditory comprehension and able to cooperate with study procedures. 8. Written informed consent provided by the participant and/or family member, as applicable.
Exclusion criteria
1. Other neurological or mental system disorders 2. Severe sensory impairment. 3. Severe cardiac, pulmonary, hepatic, or renal disease. 4. History of seizures after stroke. 5. Allergy in the relevant treatment area, or other contraindications to the study stimulation procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Functional Oral Intake Scale (FOIS) | Baseline and immediately after completion of the 2-week intervention | The Functional Oral Intake Scale (FOIS) is a 7-point ordinal scale used to assess the functional level of oral food and liquid intake. Scores range from 1 (nothing by mouth) to 7 (total oral diet with no restrictions). Higher scores indicate better funct |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penetration-Aspiration Scale (PAS) Score | Baseline and immediately after completion of the 2-week intervention | The Penetration-Aspiration Scale (PAS) is an 8-point ordinal scale used to assess the severity of airway invasion during swallowing. Scores range from 1 to 8, with a score of 1 indicating that material does not enter the airway and a score of 8 indicating that material passes below the vocal folds with no attempt to eject it. Higher scores indicate greater severity of penetration or aspiration. |
| Dysphagia Outcome and Severity Scale (DOSS) Score | Baseline and immediately after completion of the 2-week intervention | The Dysphagia Outcome and Severity Scale (DOSS) is a 7-point ordinal scale used to assess the functional severity of dysphagia and the level of dietary restriction and assistance required. Scores range from 1 to 7, with a score of 1 indicating severe dysphagia with inability to safely tolerate oral intake and a score of 7 indicating normal swallowing with a regular diet and no need for compensatory strategies or additional time. Higher scores indicate better swallowing function and lower severity of dysphagia. |
Contacts
CONTACTZhiming Tang
Outcome results
None listed