Using Capsaicin to Treat Swallowing Difficulties After Stroke
Capsaicin for Post-stroke Dysphagia
This study is testing if a spicy ingredient called Capsaicin can help people who have trouble swallowing after a stroke feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cantonal Hospital of St. Gallen Academic / other |
| Locations | 1 site (St. Gallen, Saint Gallen) |
| Trial ID | NCT04470752 on ClinicalTrials.gov |
What this trial studies
This Phase 2 trial evaluates the effectiveness of oral Capsaicin in patients experiencing dysphagia following an acute ischemic stroke. Participants will be randomly assigned to receive either Capsaicin or a placebo, with treatment administered three times daily during meals or swallowing exercises supervised by a Speech Language Pathologist. After a week, patients with ongoing dysphagia will continue treatment for an additional 23 days, followed by a final swallowing assessment. The study aims to gather data on the efficacy of Capsaicin in improving swallowing function in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults who have suffered an acute ischemic stroke and have a significant impairment in oral intake.
Not a fit: Patients with dysphagia due to causes other than ischemic stroke or those with severe pre-existing swallowing difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve swallowing function in patients recovering from stroke-related dysphagia.
How similar studies have performed: While the use of Capsaicin for dysphagia is a novel approach, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute ischemic Stroke * Impairment of oral intake with FOIS ≤ 4 * Magnetic Resonance Imaging of the brain or CT scan with the finding of a subacute ischemic stroke * Informed Consent within 48 hours after admission, following initial swallowing assessment Exclusion Criteria: * Diagnosis other than ischemic stroke * Late patient admission \>48 hours after stroke onset * Impairment of functional oral intake scale ≥ 5 * FEES \>72h after admission * PAS \<2 * Pre-existing dysphagia * Dysphagia due to other cause * No evidence of stroke on imaging * Recurrent stroke = at least one stroke in the course of the study apart from the index stroke * Age \<18 years * Current drug abuse * Amphetamine or amphetamine-like Medication * Regular oral treatment with chilli pepper extract * Allergies or known adverse reactions to the consumption of chilli pepper or capsaicin * Personality disorder * Severe dementia or delirium * Other reasons according to physician/investigator because of which the patient cannot participate in the study (not suitable for treatment or examinations) * withdrawal of consent by participant at any time of the study
Where this trial is running
St. Gallen, Saint Gallen
- Kantonsspital St. Gallen — St. Gallen, Saint Gallen, Switzerland (Recruiting)
Study contacts
- Principal investigator: Georg kägi, Dr. med. — Cantonal Hospital St. Gallen
- Study coordinator: Georg Kägi, Dr.med.
- Email: georg.kaegi@kssg.ch
- Phone: +41 71 494 3594
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.