Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01777672
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2013-01-21
Brief Title:
Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia
Sponsor:
Hospital de Mataró
Organization:
Hospital de Mataró
Study Overview
Official Title:
Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia OD A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-02
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:
None
Brief Summary:
Oropharyngeal dysphagia OD is a major complaint among many patients with stroke and causes severe complications There is no specific treatment for these patients Impaired swallow response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed airway protection Swallow response is initiated by sensory afferent fibers in the oropharynx and cerebral cortex reaching the central swallowing pattern generator CPG in the medulla oblongata and brainstem motor nuclei Hypothesis Stimulation of pharyngeal sensory afferent fibers through TRPV1 receptors and electrical stimuli might enhance the stimulation of the CPG and speed the swallow response Long-term treatment of OD will improve clinical outcome of stroke patients Aim To assess the effect of TRPV1 agonists capsaicin and that of sensorial pharyngeal electrical stimulation intrapharyngeal and transcutaneous on VFS signs and swallow response at 3 6 and 12 months after treatment in stroke patients with established OD To compare the clinical effect of classical rehabilitation strategies with that of these new afferent sensorial neurostimulation strategies in terms of nutritional status parameters incidence of aspiration pneumonia andor low respiratory tract infection quality of life and mortality Methods Clinical screening of OD with the volume-viscosity swallow test and assessment by VFS and quantitative measurements of swallow response Randomized controlled trial assessing the effect of standard rehabilitation with that of afferent sensorial neurostimulation strategies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None