Stroke Clinical Trial
Official title:
Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia. Short-term Neurophysiological Effects.
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 0.2 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 (pre/post evaluation with VFS/pSEP/pMEP)
+ 1 separate control session 1 week apart (pre/post evaluation with VFS/pSEP/pMEP).
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