Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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).
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rtMS) | Active Comparator | Acute repetitive transcranial magnetic stimulation on the pharyngeal sensory cortex. Applied intensity 90% of the resting motor threshold, 1250 pulses at 5 Hz. Each treatment arm was placebo/sham compared with a time separation of one week. The assignment to either active or sham was randomized. |
|
| Intrapharyngeal electrical stimulation (PES) | Active Comparator | Intrapharyngeal electrical stimulation applied to an intensity of 75% of the tolerance threshold with 0.2 ms pulses at 5 Hz during 10 min. Each treatment arm was placebo/sham compared with a time separation of one week. The assignment to either active or sham was randomized. |
|
| Capsaicin | Active Comparator | 100 mL of oral capsaicin solution at a concentration of 10-5M. Each treatment arm was placebo/sham compared with a time separation of one week. The assignment to either active or sham was randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS active and sham | Device | Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharyngeal motor evoked potential (pMEP): latency and amplitude | 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. | The event wil be assessed with pMEP immediately after the application of the intervention (time frame maximum up to 2 hours). |
| Pharyngeal sensory evoked potential (pSEP): latency and amplitude | 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. | The event wil be assessed with pSEPs immediately after the application of the intervention (time frame maximum up to 2 hours). |
| Penetration-aspiration scale (PAS) score | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Opening and closing time of the laryngeal vestibule | Time of the laryngeal vestibule opening and closure ranges from 0 to 1000 ms. | The event wil be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). |
| Prevalence of pharyngeal residue |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pere Clavé, PhD | Hospital de Mataró | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PES active and sham | Device | Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses. |
|
|
| Capsaicin active and placebo | Dietary Supplement | Capsaicin solution (TRPV1 agonist) at a concentration of 10-5M or placebo solution. |
|
|
The presence of pharyngeal residue in individual subjects will be assessed. |
| The event will be assessed with VFS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). |
| Resting motor threshold (RMT) of the pharyngeal cortex | 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. | The event wil be assessed with TMS immediately after the application of the intervention (time frame maximum up to 2 hours from first assessment). |
| Pharyngeal sensory thresholds | 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. | 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). |
| Incidence of Treatment-Emergent Adverse Events | 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. | Although its occurrence is early after the TMS session, seizures and other side effects will be monitored up to 3 months after the intervention. |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |