Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04052178
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2019-08-02
Brief Title:
Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia
Sponsor:
Hospital de Mataró
Organization:
Hospital de Mataró
Study Overview
Official Title:
Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia Short-term Neurophysiological Effects
Status:
COMPLETED
Status Verified Date:
2019-08
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:
FIS2014
Brief Summary:
Study design Multicenter experimental randomized crossed double blind study patient and results analysis
Aim To evaluate the effect of different neurostimulation techniques on the neurophysiological and biomechanical swallowing mechanisms of patients with dysphagia associated with chronic stroke and select those techniques with the best results to be evaluated in the second phase of the study medium-term effects
Outcome measures
Videofluoroscopy prevalence of impaired efficacy and safety of swallow penetrations and aspirations penetration aspiration scale PAS from 0 to 8 biomechanical parameters time to laryngeal vestibule closure upper esophageal sphincter opening
Pharyngeal sensory evoked potentials pSEP latency and amplitude of obtained evoked potentials Higher latency 0 onwards means worse outcome and higher amplitude 0 onwards means better outcome
Pharyngeal motor evoked potentials pMEP latency amplitude duration and area of obtained evoked potentials Higher latency 0 onwards means worse outcome and higher amplitude 0 onwards means better outcome
Treatments and patients 36 post-stroke patients with oropharyngeal dysphagia PAS superior or equal to 2 randomized patients in 3 treatment arms 3 groups of 12 patients
Active and sham repetitive transcranial magnetic stimulation rTMS 90 of the resting motor threshold 1250 pulses 5 Hz
Active and sham Intrapharyngeal Electrical Stimulation PES 75 of tolerance threshold pulses of 02 ms 5 Hz 10 min
Oral Capsaicin active intervention 10-5M TRPV1 agonist and placebo solution sham 100 mL single administration
Administration of study therapies
The study will be performed in two visits separated for one week In each visit patients will randomly receive active or sham treatment and a pre-post evaluation of biomechanics of deglutition with VFS and neurophysiological mechanisms swallowing afferent and efferent pathways will be performed in each visit
Acute randomized administration - 1 active session prepost evaluation with VFSpSEPpMEP 1 separate control session 1 week apart prepost evaluation with VFSpSEPpMEP
Aim To evaluate the effect of different neurostimulation techniques on the neurophysiological and biomechanical swallowing mechanisms of patients with dysphagia associated with chronic stroke and select those techniques with the best results to be evaluated in the second phase of the study medium-term effects
Outcome measures
Videofluoroscopy prevalence of impaired efficacy and safety of swallow penetrations and aspirations penetration aspiration scale PAS from 0 to 8 biomechanical parameters time to laryngeal vestibule closure upper esophageal sphincter opening
Pharyngeal sensory evoked potentials pSEP latency and amplitude of obtained evoked potentials Higher latency 0 onwards means worse outcome and higher amplitude 0 onwards means better outcome
Pharyngeal motor evoked potentials pMEP latency amplitude duration and area of obtained evoked potentials Higher latency 0 onwards means worse outcome and higher amplitude 0 onwards means better outcome
Treatments and patients 36 post-stroke patients with oropharyngeal dysphagia PAS superior or equal to 2 randomized patients in 3 treatment arms 3 groups of 12 patients
Active and sham repetitive transcranial magnetic stimulation rTMS 90 of the resting motor threshold 1250 pulses 5 Hz
Active and sham Intrapharyngeal Electrical Stimulation PES 75 of tolerance threshold pulses of 02 ms 5 Hz 10 min
Oral Capsaicin active intervention 10-5M TRPV1 agonist and placebo solution sham 100 mL single administration
Administration of study therapies
The study will be performed in two visits separated for one week In each visit patients will randomly receive active or sham treatment and a pre-post evaluation of biomechanics of deglutition with VFS and neurophysiological mechanisms swallowing afferent and efferent pathways will be performed in each visit
Acute randomized administration - 1 active session prepost evaluation with VFSpSEPpMEP 1 separate control session 1 week apart prepost evaluation with VFSpSEPpMEP
Detailed Description:
None
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