Capsaicin for Post-stroke Dysphagia
- Conditions
- Dysphagia, Late Effect of Stroke
- Interventions
- Drug: InOrpha Solution
- Registration Number
- NCT04470752
- Lead Sponsor
- Georg Kägi, MD
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Capsaicin Capsaicin 1% oral solution InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days. Placebo InOrpha Solution InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.
- Primary Outcome Measures
Name Time Method Penetration Aspiration Scale (PAS) score 7 days after randomisation the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.
- Secondary Outcome Measures
Name Time Method Functional Oral Intake Scale (FOIS) score at day 7 and 30 post admission Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)
number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement from randomisation until day 30 Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement
Latency of the Swallowing reflex from randomisation until day 30 Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex
Swallowing quality of life questionnaire (Swal-QoL) score from randomisation until day 30 Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke after 7 and 30 days post admission admission of patients with and without sensory deficits (only supratentorial strokes)
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke after 7 and 30 days post admission of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections
days of nasogastric tube feeding from randomisation until day 30 Between group differences (capsaicin / placebo) of days of nasogastric tube feedings
number of patients with aspiration pneumonia from randomisation until day 30 Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia
modified Ranking Scale (mRS) score from randomisation until day 30 Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)
Trial Locations
- Locations (1)
Kantonsspital St. Gallen
🇨🇭St. Gallen, Saint Gallen, Switzerland