DysphagiaPhase 2NCT01777672
Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia
A Phase 2 study testing Dietary and oral hygiene recommendations, oral TRPV1 agonist and pharyngeal electrical stimulation in people with Dysphagia and Aspiration, run by Hospital de Mataró at 1 site in Spain.
Trial summary
Oropharyngeal dysphagia (OD) is a major complaint among many patients with stroke and causes severe complications. There is no specific treatment for these patients. Impaired swallow response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed airway protection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysphagia, Aspiration, Stroke
- What is being tested?
- Dietary and oral hygiene recommendations, oral TRPV1 agonist and pharyngeal electrical stimulation
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2012to Jun 2016
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Person with persistent clinical signs or symptoms of OD according to V-VST and confirmed with VFS (PA scale level 3 or more) secondary to a stroke episode in the last 3 months.
Who cannot join
- Patient unconscious or in a coma
- Patients diagnosed with transitory ischemic accident
- life expectancy less than 3 months
- neurodegenerative disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia (OD). A Randomized Controlled Trial.
Oropharyngeal dysphagia (OD) is a major complaint among many patients with stroke and causes severe complications. There is no specific treatment for these patients. Impaired swallow response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed airway protection. Swallow response is initiated by sensory afferent fibers in the oropharynx and cerebral cortex reaching the central swallowing pattern generator (CPG) in the medulla oblongata and brainstem motor nuclei. Hypothesis: Stimulation of pharyngeal sensory afferent fibers through TRPV1 receptors and electrical stimuli might enhance the stimulation of the CPG and speed the swallow response. Long-term treatment of OD will improve clinical outcome of stroke patients. Aim: To assess the effect of TRPV1 agonists (capsaicin) and that of sensorial pharyngeal electrical stimulation (intrapharyngeal and transcutaneous) on VFS signs and swallow response at 3, 6 and 12 months after treatment in stroke patients with established OD. To compare the clinical effect of classical rehabilitation strategies with that of these new afferent sensorial neurostimulation strategies in terms of nutritional status parameters, incidence of aspiration pneumonia and/or low respiratory tract infection, quality of life, and mortality. Methods: Clinical screening of OD with the volume-viscosity swallow test and assessment by VFS and quantitative measurements of swallow response. Randomized controlled trial assessing the effect of standard rehabilitation with that of afferent sensorial neurostimulation strategies.
- Conditions
- Dysphagia, Aspiration, Stroke
- Being tested
- Dietary and oral hygiene recommendations, oral TRPV1 agonist, pharyngeal electrical stimulation, transcutaneous electrical 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.
Dietary and oral hygiene recommendationsBehavioural
oral TRPV1 agonistDietary supplement
Patients will receive the administration of a TRPV1 agonist (natural capsaicin) supplement before each meal, 3 meals/day, 5 days/week for 2 consecutive weeks. The TRPV1 agonist will be provided by the pharmacy of the center.
pharyngeal electrical stimulationDevice
Also called Electrodes (Gaeltec, Ltd, Dunvegan, Isle of Skye, UK., Electrical stimulator (Grass Instruments Co, USA)
Includes neuron stimulation treatment of 1 session / day of pharyngeal electrical stimulation of 10 min duration, 3 days/week during 1 week, done at the same center.
transcutaneous electrical stimulationDevice
Also called Intelect VitalStim, Chattanooga, USA)
Trans-cutaneous electrical stimuli will be applied 5 seconds every minute during 1 hour daily session, 5 days/week during 2 consecutive weeks at the same centre.
| Study group | Role | What they receive |
|---|---|---|
| Dietary and oral hygiene recommendations | Active comparator | Patients in this group will receive recommendations from their healthcare providers about bolus volume and viscosity adaptation for fluids, dietary and nutritional adjustments (liquids and solids) of bolus volume and viscosity/texture. Before leaving each hospital they will also learn basic rehabilitation strategies for OD including swallow postures, compensatory manoeuvres and oropharyngeal rehabilitation exercises and oral hygiene to follow at home. Receives: Behavioral: Dietary and oral hygiene recommendations |
| oral TRPV1 agonist | Experimental | Patients will receive the same recommendations as the control group and also recommendation for the administration of a TRPV1 agonist (natural capsaicin) supplement (5 mL bolus before each meal), 3 meals/day, 5 days/week for 2 consecutive weeks. Receives: Behavioral: Dietary and oral hygiene recommendations; Dietary Supplement: oral TRPV1 agonist |
| pharyngeal electrical stimulation | Experimental | Treatment in this group will also include the same measures as in the control group, plus neuron stimulation treatment of 1 session / day of pharyngeal electrical stimulation of 10 min duration, 3 days/week during one week, done at the same center. Receives: Behavioral: Dietary and oral hygiene recommendations; Device: pharyngeal electrical stimulation |
| transcutaneous electrical stimulation | Experimental | Treatment in this group will be the same as the control group plus trans-cutaneous electrical stimuli will be applied 5 seconds every minute during 1 hour daily session, 5 days/week during 2 consecutive weeks at the same centre. Receives: Behavioral: Dietary and oral hygiene recommendations; Device: transcutaneous electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy and safety of new neuron-stimulation treatments for OD in patients with stroke and to explore their mechanism of action.
The efficacy of each treatment will be assessed by VFS in each patient after the treatment and at the end of the follow-up period, considering Rosenbek scale and measures of oropharyngeal swallow response including oropharyngeal reconfiguration, timing and extent of hyoid motion and bolus propulsion force of the tongue. Clinical outcome also evaluated are episodes of aspiration pneumonia and low respiratory tract infections, nutritional status, complications and clinical symptoms experimented during one year of follow-up and mortality rates and cause of death.
Participating clinicians will be instructed to register and describe all serious adverse events (SAE) occurred during the study and report them on a specific form within 24 hours. The guidelines for SAE reporting to the Ethical Committee and competent authorities will be followed.
Measured: 12 months
Secondary outcomes (1)
To determine the prevalence of OD and its complications in stroke patients over one year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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 Pere, Doctor, Principal investigator, Hospital de Mataró, Gastrointestinal Physiology Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777672
- Sponsor's protocol ID
- Marató-11
- Status last verified
- Feb 2017
- First submitted
- 21 Jan 2013
- Last updated
- 9 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia (OD). A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01777672
- Acronym / sponsor ID
- Marató-11
- Conditions
- Dysphagia, Aspiration, Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (actual)
- First posted
- 29 Jan 2013 (estimated)
- 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.
Oropharyngeal dysphagia (OD) is a major complaint among many patients with stroke and causes severe complications. There is no specific treatment for these patients. Impaired swallow response is caused by a delay in the timing of oropharyngeal reconfiguration with delayed airway protection. Swallow response is initiated by sensory afferent fibers in the oropharynx and cerebral cortex reaching the central swallowing pattern generator (CPG) in the medulla oblongata and brainstem motor nuclei. Hypothesis: Stimulation of pharyngeal sensory afferent fibers through TRPV1 receptors and electrical stimuli might enhance the stimulation of the CPG and speed the swallow response. Long-term treatment of OD will improve clinical outcome of stroke patients. Aim: To assess the effect of TRPV1 agonists (capsaicin) and that of sensorial pharyngeal electrical stimulation (intrapharyngeal and transcutaneous) on VFS signs and swallow response at 3, 6 and 12 months after treatment in stroke patients with established OD. To compare the clinical effect of classical rehabilitation strategies with that of these new afferent sensorial neurostimulation strategies in terms of nutritional status parameters, incidence of aspiration pneumonia and/or low respiratory tract infection, quality of life, and mortality. Methods: Clinical screening of OD with the volume-viscosity swallow test and assessment by VFS and quantitative measurements of swallow response. Randomized controlled trial assessing the effect of standard rehabilitation with that of afferent sensorial neurostimulation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dietary and oral hygiene recommendations | Active comparator | Behavioral: Dietary and oral hygiene recommendationsPatients in this group will receive recommendations from their healthcare providers about bolus volume and viscosity adaptation for fluids, dietary and nutritional adjustments (liquids and solids) of bolus volume and viscosity/texture. Before leaving each hospital they will also learn basic rehabilitation strategies for OD including swallow postures, compensatory manoeuvres and oropharyngeal rehabilitation exercises and oral hygiene to follow at home. |
| oral TRPV1 agonist | Experimental | Behavioral: Dietary and oral hygiene recommendations, Dietary Supplement: oral TRPV1 agonistPatients will receive the same recommendations as the control group and also recommendation for the administration of a TRPV1 agonist (natural capsaicin) supplement (5 mL bolus before each meal), 3 meals/day, 5 days/week for 2 consecutive weeks. |
| pharyngeal electrical stimulation | Experimental | Behavioral: Dietary and oral hygiene recommendations, Device: pharyngeal electrical stimulationTreatment in this group will also include the same measures as in the control group, plus neuron stimulation treatment of 1 session / day of pharyngeal electrical stimulation of 10 min duration, 3 days/week during one week, done at the same center. |
| transcutaneous electrical stimulation | Experimental | Behavioral: Dietary and oral hygiene recommendations, Device: transcutaneous electrical stimulationTreatment in this group will be the same as the control group plus trans-cutaneous electrical stimuli will be applied 5 seconds every minute during 1 hour daily session, 5 days/week during 2 consecutive weeks at the same centre. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Person with persistent clinical signs or symptoms of OD according to V-VST and confirmed with VFS (PA scale level 3 or more) secondary to a stroke episode in the last 3 months.
Key exclusion criteria (4 listed)
- Patient unconscious or in a coma
- Patients diagnosed with transitory ischemic accident
- life expectancy less than 3 months
- neurodegenerative disease
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 |
|---|---|---|
| Dietary and oral hygiene recommendations | Behavioural | Dietary and oral hygiene recommendations, oral TRPV1 agonist, pharyngeal electrical stimulation, transcutaneous electrical stimulation |
| oral TRPV1 agonistPatients will receive the administration of a TRPV1 agonist (natural capsaicin) supplement before each meal, 3 meals/day, 5 days/week for 2 consecutive weeks. The TRPV1 agonist will be provided by the pharmacy of the center. | Dietary supplement | oral TRPV1 agonist |
| pharyngeal electrical stimulationAlso: Electrodes (Gaeltec, Ltd, Dunvegan, Isle of Skye, UK., Electrical stimulator (Grass Instruments Co, USA)Includes neuron stimulation treatment of 1 session / day of pharyngeal electrical stimulation of 10 min duration, 3 days/week during 1 week, done at the same center. | Device | pharyngeal electrical stimulation |
| transcutaneous electrical stimulationAlso: Intelect VitalStim, Chattanooga, USA)Trans-cutaneous electrical stimuli will be applied 5 seconds every minute during 1 hour daily session, 5 days/week during 2 consecutive weeks at the same centre. | Device | transcutaneous electrical stimulation |
Primary outcome
To assess the efficacy and safety of new neuron-stimulation treatments for OD in patients with stroke and to explore their mechanism of action.
Time frame: 12 months
The efficacy of each treatment will be assessed by VFS in each patient after the treatment and at the end of the follow-up period, considering Rosenbek scale and measures of oropharyngeal swallow response including oropharyngeal reconfiguration, timing and extent of hyoid motion and bolus propulsion force of the tongue. Clinical outcome also evaluated are episodes of aspiration pneumonia and low respiratory tract infections, nutritional status, complications and clinical symptoms experimented during one year of follow-up and mortality rates and cause of death. Participating clinicians will be instructed to register and describe all serious adverse events (SAE) occurred during the study and report them on a specific form within 24 hours. The guidelines for SAE reporting to the Ethical Committee and competent authorities will be followed.
1 secondary outcome
To determine the prevalence of OD and its complications in stroke patients over one year.
Time frame: 12 months
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 9 Feb 2017.
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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 Pere, Doctor principal investigator
Hospital de Mataró, Gastrointestinal Physiology Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dietary and oral hygiene recommendations, oral TRPV1 agonist and pharyngeal electrical stimulation in people with Dysphagia and Aspiration, run by Hospital de Mataró at 1 site in Spain.
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 1 inclusion and 4 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To assess the efficacy and safety of new neuron-stimulation treatments for OD in patients with stroke and to explore their mechanism of action. (time frame: 12 months). 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 9 Feb 2017.