Status:
UNKNOWN
Capsaicin for Post-stroke Dysphagia
Lead Sponsor:
Georg Kägi, MD
Collaborating Sponsors:
Cantonal Hospital of Aarau, Switzerland
University Hospital, Basel, Switzerland
Conditions:
Dysphagia, Late Effect of Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.
Detailed Description
After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES) patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be applied 3 times dail...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04470752
Start Date
August 24 2021
End Date
December 1 2024
Last Update
June 22 2023
Active Locations (1)
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1
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007