Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05735626
Status:
RECRUITING
Last Update Posted:
2023-02-21
First Post:
2023-01-17
Brief Title:
Treatment of Acute Post-stroke Oropharyngeal Dysphagia With Paired Stimulation
Sponsor:
Hospital de Mataró
Organization:
Hospital de Mataró
Study Overview
Official Title:
Treatment of Acute Post-stroke Oropharyngeal Dysphagia With Paired Stimulation Through Peripheral TRVP1 Agonists and Non-invasive Brain Stimulation
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICI2000117
Brief Summary:
According WHO oropharyngeal dysphagia OD is a prevalent post-stroke PS condition involving the digestive system ICD-10 I69391 and an independent risk factor for malnutrition and pulmonary infection and leads to greater morbimortality and healthcare costs and poorer quality of life QoL Currently OD therapy is mainly compensatory with low rates of compliance and small benefit and there is no pharmacological treatment so new treatments that improve patients condition are crucial PS-OD patients present both oropharyngeal sensory and motor deficits so neurorehabilitation treatments which target both could be optimum Benefits of paired peripheral sensory stimulation with oral capsaicin or piperine and of central motor noninvasive brain stimulation techniques such as transcranial direct current stimulation tDCS will be studied Pairing sensory peripheral and central stimulation may produce greater benefits The main aim of the project is to study the efficacy of a novel protocol of paired stimulation on acute PS-OD patients The investigators will assess the acute application of tDCSpiperine or tDCScapsaicin in the acute phase of stroke will improve PS-OD 2 days randomized crossover study with 60 patients in 3 treatment groups 60 patients in the acute stroke phase divided in 3 study arms We will assess changes in swallow safety and neurophysiology of the swallow hospital stay respiratory and nutritional complications mortality and QoL
Detailed Description:
Main hypothesis Paired neurorehabilitation treatment targeting both pharyngeal sensory and motor components simultaneously through a peripheral pharmacological stimulant transient receptor potential cation channel TRPV1 agonist capsaicin and central stimulation NIBS tDCS can improve swallowing function in acute PS-OD patients by promoting cortical plasticity their QoL and reduce OD associated complications
Main objectives to study the efficacy of a novel protocol of paired stimulation on acute PS-OD patients The investigators will assess the acute application of tDCSpiperine or tDCScapsaicin in the acute phase of stroke
Secondary aims to assess 1 safety and adverse events 2 the effects on safety of swallow with a standardized protocol of swallowing evaluation 3 clinical outcomes at 3 months follow up 4 the effect of the treatments on spontaneous swallowing frequency and responsiveness to treatment according to stroke characteristics 5 the effect in the acute phase on functional severity of OD and specific clinical outcomes
Design 2 days randomized crossover study with 60 patients in 3 treatment groups 60 patients in the acute stroke phase divided in 3 study arms We will assess changes in swallow safety and neurophysiology of the swallow hospital stay respiratory and nutritional complications mortality and QoL
Study population 60 Acute PS-OD hospitalized patients
Inclusion criteria Adult patients consecutively admitted with recent 1month unilateral hemispheric stroke impaired safety of swallow ISS V-VST conscious NIHSS quest 1a0 able to follow the protocol and to give written informed consent WIC
Exclusion criteria Pregnancy life expectancy 3m or palliative care neurodegenerative disorder or previous OD implanted electronic device epilepsy metal in the head participation in another clinical trial in the previous month
Main objectives to study the efficacy of a novel protocol of paired stimulation on acute PS-OD patients The investigators will assess the acute application of tDCSpiperine or tDCScapsaicin in the acute phase of stroke
Secondary aims to assess 1 safety and adverse events 2 the effects on safety of swallow with a standardized protocol of swallowing evaluation 3 clinical outcomes at 3 months follow up 4 the effect of the treatments on spontaneous swallowing frequency and responsiveness to treatment according to stroke characteristics 5 the effect in the acute phase on functional severity of OD and specific clinical outcomes
Design 2 days randomized crossover study with 60 patients in 3 treatment groups 60 patients in the acute stroke phase divided in 3 study arms We will assess changes in swallow safety and neurophysiology of the swallow hospital stay respiratory and nutritional complications mortality and QoL
Study population 60 Acute PS-OD hospitalized patients
Inclusion criteria Adult patients consecutively admitted with recent 1month unilateral hemispheric stroke impaired safety of swallow ISS V-VST conscious NIHSS quest 1a0 able to follow the protocol and to give written informed consent WIC
Exclusion criteria Pregnancy life expectancy 3m or palliative care neurodegenerative disorder or previous OD implanted electronic device epilepsy metal in the head participation in another clinical trial in the previous month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None