Dysphagia, Neurophysiologic Abnormality, Stroke, Swallowing Disorder
Conditions
Keywords
Oropharyngeal dysphagia, Stroke, Sensory stimulation
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 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).
Interventions
DEVICErTMS active and sham
Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex.
DEVICEPES active and sham
Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses.
DIETARY_SUPPLEMENTCapsaicin active and placebo
Capsaicin solution (TRPV1 agonist) at a concentration of 10-5M or placebo solution.
Sponsors
Hospital de Mataró
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years. * Patients with a diagnosis of stroke of more than 3 months of evolution. * Patients with clinical signs of dysphagia according to the volume viscosity swallowing test (V-VST). * Patients capable of complying with the study protocol. * Explained study and signed informed consent.
Exclusion criteria
* History of severe neurodegenerative, digestive diseases, epilepsy or previous seizures. * Pacemaker or implanted defibrillator carriers. * Implanted electrode carriers or other stimulation systems. * Implant carriers or metal plates on the head or neck. * Cochlear implant carriers. * Medication pump carriers. * History of hearing loss associated with noise. * Cardiopulmonary instability. * Oropharyngeal dysphagia of structural causes. * History of head and neck surgery. * Alcohol or drug dependence. * Pregnancy or breastfeeding. * Participate or have participated in another clinical interventionist trial in the 4 weeks prior to inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharyngeal motor evoked potential (pMEP): latency and amplitude | The event wil be assessed with pMEP immediately after the application of the intervention (time frame maximum up to 2 hours). | Study the magnitude of the effect by calculating the change of the evoked potential from baseline immediately after the application of the intervention produced by the different treatments. This will be examined and compared between active and sham intervention. |
| Pharyngeal sensory evoked potential (pSEP): latency and amplitude | The event wil be assessed with pSEPs immediately after the application of the intervention (time frame maximum up to 2 hours). | Study the magnitude of the effect by calculating the change of the evoked potential from baseline immediately after the application of the intervention produced by the different treatments. This will be examined and compared between active and sham intervention. |
| Penetration-aspiration scale (PAS) score | The event wil be assessed with the PAS score immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). | Study the magnitude of the effect by calculating the change on the prevalence of unsafe swallow (PAS≥2) in videofluoroscopy (VFS) from baseline immediately after the application of the intervention. This will be examined and compared between active and sham intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharyngeal sensory thresholds | The event wil be assessed with pharyngeal electrical stimulation immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). | First perception and tolerance thresholds (from 0 to 100 mA) to electrical stimulation of the pharynx will be assessed by asking subjects the exact moment of first perception of the stimulus and the moment in which stimulation is not further tolerated, respectively. |
| Opening and closing time of the laryngeal vestibule | The event wil be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). | Time of the laryngeal vestibule opening and closure ranges from 0 to 1000 ms. |
| Incidence of Treatment-Emergent Adverse Events | Although its occurrence is early after the TMS session, seizures and other side effects will be monitored up to 3 months after the intervention. | Seizures are the most feared side effect associated with transcranial magnetic stimulation (TMS). Seizures are a rare side event during and/or subsequent to a TMS session (1.4%, Bae et al., 2007) commonly not occurring beyond a few days after the last session. No other major or significant side effects are expected associated with the interventions. |
| Prevalence of pharyngeal residue | The event will be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). | The presence of pharyngeal residue in individual subjects will be assessed. |
| Resting motor threshold (RMT) of the pharyngeal cortex | The event wil be assessed with TMS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). | RMT is defined as the stimulation intensity in which the half of the stimuli are able to evoke a motor evoked potential of al least 10 uV of amplitude. |
Outcome results
None listed