Evaluation of a new electric stimulation device for treating swallowing difficulties
Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism
This study is testing a new electric stimulation device to see if it can help people with swallowing difficulties feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT05483582 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the safety and effectiveness of a 4-channel electric stimulation device for patients with dysphagia. Participants will be divided into two groups to receive different protocols of electrical stimulation, with outcomes measured using various scales such as the Videofluoroscopic Dysphagia Scale and the Penetration Aspiration Scale. The study will also evaluate the impact on dietary status and quality of life related to dysphagia. The findings will help determine the necessary sample size for future clinical trials.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 90 with oropharyngeal dysphagia confirmed by video fluoroscopy.
Not a fit: Patients with dysphagia due to respiratory failure or those who have undergone certain surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from dysphagia.
How similar studies have performed: While this approach is novel, similar studies have shown promise in using electrical stimulation for dysphagia treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with oropharyngeal dysphagia confirmed by video fluoroscopy * Patients with oropharyngeal dysphagia due to central nervous system disease who clinically require application of an electrical stimulation treatment device for dysphagia * Patients aged between 19 and under 90 years of age regardless of gender * Those who voluntarily consent to the clinical trial and can visit for the next observation * Patients with dysphagia within 6 months (including patients with dysphagia due to stroke, traumatic brain injury, cervical spine injury, etc.) Exclusion Criteria: * In case of refusal of inspection * Who do not agree * When instructions cannot be performed due to mental illness, etc. * Those who have dysphagia due to respiratory failure, cervical spine surgery, head and neck surgery, and chemotherapy and radiation treatment of the neck * Pregnant and lactating women * Pre-interview is conducted only with women of childbearing age to determine whether they are pregnant or lactating. If pregnancy is confirmed during the pre-interview, it is excluded from the test. * Patients who cannot apply electrical stimulation therapy due to allergies or hypersensitivity reactions * Others who have comorbidities (e.g., malignant tumors, severe renal/liver/lung diseases, blood clotting abnormalities, etc.) that are inappropriate for participation in clinical trials as judged by the researcher * Persons with pacemakers and other internal electrical stimulators * Those who are participating in other clinical trials at the time of screening * Those who are judged by other researchers to be inappropriate for this clinical trial
Where this trial is running
Seongnam-si, Gyeonggi-do
- Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine — Seongnam-si, Gyeonggi-do, Korea, Republic of (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.