Swallowing DisorderFIS2014NCT04052178
Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia.
A study of Swallowing Disorder and Dysphagia, run by Hospital de Mataró.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Disorder, Dysphagia, Stroke
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2016to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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).
Read more
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).
- Conditions
- Swallowing Disorder, Dysphagia, Stroke, Neurophysiologic Abnormality
- Being tested
- rTMS active and sham, PES active and sham, Capsaicin active and placebo
- Keywords
- Oropharyngeal dysphagia, Stroke, Sensory stimulation
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS active and shamDevice
Also called Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex.
PES active and shamDevice
Also called Intrapharyngeal electrical stimulation
Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses.
Capsaicin active and placeboDietary supplement
Also called TRPV1 agonist (capsaicin at 10-5M) or placebo
Capsaicin solution (TRPV1 agonist) at a concentration of 10-5M or placebo solution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: rTMS active and sham |
| 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. Receives: Device: PES active and sham |
| 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 Receives: Dietary Supplement: Capsaicin active and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Secondary outcomes (5)
Opening and closing time of the laryngeal vestibule
Time of the laryngeal vestibule opening and closure ranges from 0 to 1000 ms.
Measured: 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
The presence of pharyngeal residue in individual subjects will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Although its occurrence is early after the TMS session, seizures and other side effects will be monitored up to 3 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start10 Feb 2016
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Mataró
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Clave, Hospital de Mataró
- Investigators
- Pere Clavé, PhD, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052178
- Sponsor's protocol ID
- FIS2014
- Acronym
- FIS2014
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Neuromodulation Protocol for the Treatment of Post-stroke Oropharyngeal Dysphagia. Short-term Neurophysiological Effects.
- ClinicalTrials.gov ID
- NCT04052178
- Acronym / sponsor ID
- FIS2014 / FIS2014
- Conditions
- Swallowing Disorder, Dysphagia, Stroke, Neurophysiologic Abnormality
- Keywords
- Oropharyngeal dysphagia, Stroke, Sensory stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rtMS) | Active comparator | Device: rTMS active and shamAcute 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 | Device: PES active and shamIntrapharyngeal 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 | Dietary Supplement: Capsaicin active and placebo100 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS active and shamAlso: Repetitive transcranial magnetic stimulationRepetitive transcranial magnetic stimulation of the pharyngeal sensory cortex. | Device | Repetitive transcranial magnetic stimulation (rtMS) |
| PES active and shamAlso: Intrapharyngeal electrical stimulationIntrapharyngeal electrical stimulation with a catheter delivering electrical pulses. | Device | Intrapharyngeal electrical stimulation (PES) |
| Capsaicin active and placeboAlso: TRPV1 agonist (capsaicin at 10-5M) or placeboCapsaicin solution (TRPV1 agonist) at a concentration of 10-5M or placebo solution. | Dietary supplement | Capsaicin |
Primary outcome
Pharyngeal motor evoked potential (pMEP): latency and amplitude
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Opening and closing time of the laryngeal vestibule
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Although its occurrence is early after the TMS session, seizures and other side effects will be monitored up to 3 months after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pere Clavé, PhD principal investigator
Hospital de Mataró
Questions about this trial
What is this clinical trial studying?
A study of Swallowing Disorder and Dysphagia, run by Hospital de Mataró.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharyngeal motor evoked potential (pMEP): latency and amplitude (time frame: The event wil be assessed with pMEP immediately after the application of the intervention (time frame maximum up to 2 hours).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.