Capsaicin for Post-stroke Dysphagia

Capsaicin for Post-stroke Dysphagia

Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.

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 daily either during meals or during regular swallowing tests/trainings accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7 days, patients with persistent dysphagia and applicable for further treatment will be treated for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A Patient Medication Diary will used during the Duration of the Trial to capture compliance.

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