Dysphagia, Late Effect of Stroke
Conditions
Keywords
Dysphagia, Stroke
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.
Interventions
DRUGCapsaicin 1% oral solution
Capsaicin 1.0 micrograms/ml
DRUGInOrpha Solution
glycerol based suspension vehicle
Sponsors
Cantonal Hospital of Aarau, Switzerland
University Hospital, Basel, Switzerland
Georg Kägi, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both study drug and Placebo have identical packaging (brown glass bottle) and labeling (Capsaicin or Placebo). Both use the same liquid suspension, same colour, and consistency..
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Oral Intake Scale (FOIS) score | at day 7 and 30 post admission | Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS) |
| 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 Percutaneous endoscopic gastrostomy (PEG) tube placement | from randomisation until day 30 | Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement |
| number of patients with aspiration pneumonia | from randomisation until day 30 | Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia |
| Latency of the Swallowing reflex | from randomisation until day 30 | Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex |
| modified Ranking Scale (mRS) score | from randomisation until day 30 | Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS) |
| 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 |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (safety and tolerability) | 30 days post admission | Potential harm will be assessed by comparing between-group differences (verum/placebo) of hypothermia and other (serious) adverse events which are not known yet, but will be collected systemically during this trial. |
Countries
Switzerland
Contacts
Primary ContactGeorg Kägi, Dr.med.
Backup ContactAnna Müller, RN
Outcome results
None listed