DysphagiaNCT01762228
Efficacy of Two Interventions Increasing Sensory Stimulus in Elderly Patients With Oropharyngeal Dysphagia
A study testing Transcutaneous electrical stimulation and TRPV1 agonist in people with Dysphagia, run by Hospital de Mataró at 1 site in Spain.
Trial summary
This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia: 1. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Transcutaneous electrical stimulation and TRPV1 agonist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Mar 2015
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients (≥70 years) with oropharyngeal dysphagia (OD)
- Patients have to fill in and sign the written informed consent.
- Patients without any of the exclusion criteria.
Who cannot join
- Patients not able to comply with the protocol.
- Patients currently participating or having participated in another clinical trial in the last 4 weeks.
- Patients with active neoplasia.
- Patients with an active infectious process.
- Patients with severe dementia or inability to communicate.
- Patients with pacemakers.
Show all 9Show fewer
- Patients with implanted electrodes.
- Patients with epilepsy or convulsive disorders.
- Patients with gastroesophageal reflux disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de Mataró. Consorci Sanitari del Mareme.
Mataró, Barcelona, 08304
About this study
Official title: Randomized Controled Clinical Study to Evaluate the Efficacy of the Increase of the Sensorial Stimuli as a Therapeutic Strategy for the Treatment of Elderly Patients With Oropharyngeal Dysphagia.
This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:
- Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
- Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.
Moreover, with an electroencephalographic study we will assess the effect of both treatments in the cortical neuroplasticity.
Read the detailed description
This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:
- Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
- Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.
The study will last 5 weeks per patient. At the beginning of the study, patients will receive a videofluoroscopic evaluation and an electroencephalography (evoked potentials) to asses dysphagia and cortical activity of deglutition. After that the first day of the third week they will begin the treatment (group a or b) during 2 weeks. Finally in the fifth week an evaluation of dysphagia will be performed the same way as in week 1 to asses the effects of the treatments.
- Conditions
- Dysphagia
- Being tested
- Transcutaneous electrical stimulation, TRPV1 agonist
- Keywords
- Oropharyngeal dysphagia, Elderly, Transcutaneous electrical stimulation, TRPV1 agonist
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical stimulationDevice
Using a device which gives electrical stimulation, electrodes will be placed transcutaneously in oropharyngeal muscles of patients giving a sensorial stimuli during one hour for 5 days/week during 2 weeks of treatment.
TRPV1 agonistDietary supplement
Patient will be given a TRPV1 agonist natural product (which contains capsaicin) before every meal, during one hour for 5 days/week during 2 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneus electrical stimulation | Active comparator | Sensorial transcutaneous electrical stimulation to the pharynx and larynx will be used 1 hour/day during 5 days/week for 2 weeks. Receives: Device: Transcutaneous electrical stimulation |
| TRPV1 agonist | Active comparator | Sensorial stimulation of TRPV1 receptors into the oropharynx of patients will be used 3 times/day (before meals) during 5 days/week for 2 weeks. Receives: Dietary Supplement: TRPV1 agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal motor response measured by Videofluoroscopy.
Measured: Week 1 and 5.
Secondary outcomes (1)
Cortical activation measured by electroencephalography.
Measured: It will be assessed at the beginning and at the end of the study (first and fifth week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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
- Omar Ortega Fernández, MSc, Principal investigator, Hospital de MataróPere Clavé, MD, PhD, Study director, Hospital de MataróLaia Rofes, MSc, Principal investigator, Hospital de Mataró
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762228
- Sponsor's protocol ID
- MUTUA-12
- Status last verified
- Mar 2015
- First submitted
- 10 Oct 2012
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rofes L, Arreola V, Romea M, Palomera E, Almirall J, Cabre M, Serra-Prat M, Clave P. Pathophysiology of oropharyngeal dysphagia in the frail elderly. Neurogastroenterol Motil. 2010 Aug;22(8):851-8, e230. doi: 10.1111/j.1365-2982.2010.01521.x. Epub 2010 Jun 7.
PubMed 20529208Clave P, Arreola V, Romea M, Medina L, Palomera E, Serra-Prat M. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr. 2008 Dec;27(6):806-15. doi: 10.1016/j.clnu.2008.06.011. Epub 2008 Sep 11.
PubMed 18789561Jean A. Brain stem control of swallowing: neuronal network and cellular mechanisms. Physiol Rev. 2001 Apr;81(2):929-69. doi: 10.1152/physrev.2001.81.2.929.
PubMed 11274347Ebihara T, Sekizawa K, Nakazawa H, Sasaki H. Capsaicin and swallowing reflex. Lancet. 1993 Feb 13;341(8842):432. doi: 10.1016/0140-6736(93)93023-t. No abstract available.
PubMed 8094188Ebihara T, Takahashi H, Ebihara S, Okazaki T, Sasaki T, Watando A, Nemoto M, Sasaki H. Capsaicin troche for swallowing dysfunction in older people. J Am Geriatr Soc. 2005 May;53(5):824-8. doi: 10.1111/j.1532-5415.2005.53261.x.
PubMed 15877558Caterina MJ, Schumacher MA, Tominaga M, Rosen TA, Levine JD, Julius D. The capsaicin receptor: a heat-activated ion channel in the pain pathway. Nature. 1997 Oct 23;389(6653):816-24. doi: 10.1038/39807.
PubMed 9349813Hamamoto T, Takumida M, Hirakawa K, Tatsukawa T, Ishibashi T. Localization of transient receptor potential vanilloid (TRPV) in the human larynx. Acta Otolaryngol. 2009 May;129(5):560-8. doi: 10.1080/00016480802273108.
PubMed 18629672Carnaby-Mann GD, Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg. 2007 Jun;133(6):564-71. doi: 10.1001/archotol.133.6.564.
PubMed 17576907Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, Dowdy E. Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Ann Otol Rhinol Laryngol. 2007 Jan;116(1):36-44. doi: 10.1177/000348940711600107.
PubMed 17305276Gallas S, Marie JP, Leroi AM, Verin E. Sensory transcutaneous electrical stimulation improves post-stroke dysphagic patients. Dysphagia. 2010 Dec;25(4):291-7. doi: 10.1007/s00455-009-9259-3. Epub 2009 Oct 24.
PubMed 19856025Logemann JA. Dysphagia: evaluation and treatment. Folia Phoniatr Logop. 1995;47(3):140-64. doi: 10.1159/000266348.
PubMed 7640720
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controled Clinical Study to Evaluate the Efficacy of the Increase of the Sensorial Stimuli as a Therapeutic Strategy for the Treatment of Elderly Patients With Oropharyngeal Dysphagia.
- ClinicalTrials.gov ID
- NCT01762228
- Acronym / sponsor ID
- MUTUA-12
- Conditions
- Dysphagia
- Keywords
- Oropharyngeal dysphagia, Elderly, Transcutaneous electrical stimulation, TRPV1 agonist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital de MataróUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 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.
This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:
- Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
- Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.
Moreover, with an electroencephalographic study we will assess the effect of both treatments in the cortical neuroplasticity.
Detailed description
This study will evaluate with videofluoroscopy (radiologic method to study the deglutitive physiology) the effect on the deglutition of two therapeutic treatments with the duration of 2 weeks, based on the increase of the sensorial stimuli in older patients with oropharyngeal dysphagia:
- Stimulation of Transient Receptor Potential Vanilloid 1 (TRPV1) oropharynx chanels using a natural agonist administrated in the alimentary bolus.
- Stimulation of the sensorial neurons of the pharynx and larynx using transcutaneous electrical stimuli.
The study will last 5 weeks per patient. At the beginning of the study, patients will receive a videofluoroscopic evaluation and an electroencephalography (evoked potentials) to asses dysphagia and cortical activity of deglutition. After that the first day of the third week they will begin the treatment (group a or b) during 2 weeks. Finally in the fifth week an evaluation of dysphagia will be performed the same way as in week 1 to asses the effects of the treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneus electrical stimulation | Active comparator | Device: Transcutaneous electrical stimulationSensorial transcutaneous electrical stimulation to the pharynx and larynx will be used 1 hour/day during 5 days/week for 2 weeks. |
| TRPV1 agonist | Active comparator | Dietary Supplement: TRPV1 agonistSensorial stimulation of TRPV1 receptors into the oropharynx of patients will be used 3 times/day (before meals) during 5 days/week for 2 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly patients (≥70 years) with oropharyngeal dysphagia (OD)
- Patients have to fill in and sign the written informed consent.
- Patients without any of the exclusion criteria.
Key exclusion criteria (9 listed)
- Patients not able to comply with the protocol.
- Patients currently participating or having participated in another clinical trial in the last 4 weeks.
- Patients with active neoplasia.
- Patients with an active infectious process.
- Patients with severe dementia or inability to communicate.
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 |
|---|---|---|
| Transcutaneous electrical stimulationUsing a device which gives electrical stimulation, electrodes will be placed transcutaneously in oropharyngeal muscles of patients giving a sensorial stimuli during one hour for 5 days/week during 2 weeks of treatment. | Device | Transcutaneus electrical stimulation |
| TRPV1 agonistPatient will be given a TRPV1 agonist natural product (which contains capsaicin) before every meal, during one hour for 5 days/week during 2 weeks of treatment. | Dietary supplement | TRPV1 agonist |
Primary outcome
Oropharyngeal motor response measured by Videofluoroscopy.
Time frame: Week 1 and 5.
1 secondary outcome
Cortical activation measured by electroencephalography.
Time frame: It will be assessed at the beginning and at the end of the study (first and fifth week).
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 19 Mar 2015.
- Background: PubMed 20529208Rofes L, Arreola V, Romea M, Palomera E, Almirall J, Cabre M, Serra-Prat M, Clave P. Pathophysiology of oropharyngeal dysphagia in the frail elderly. Neurogastroenterol Motil. 2010 Aug;22(8):851-8, e230. doi: 10.1111/j.1365-2982.2010.01521.x. Epub 2010 Jun 7.
- Background: PubMed 18789561Clave P, Arreola V, Romea M, Medina L, Palomera E, Serra-Prat M. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr. 2008 Dec;27(6):806-15. doi: 10.1016/j.clnu.2008.06.011. Epub 2008 Sep 11.
- Background: PubMed 11274347Jean A. Brain stem control of swallowing: neuronal network and cellular mechanisms. Physiol Rev. 2001 Apr;81(2):929-69. doi: 10.1152/physrev.2001.81.2.929.
- Background: PubMed 8094188Ebihara T, Sekizawa K, Nakazawa H, Sasaki H. Capsaicin and swallowing reflex. Lancet. 1993 Feb 13;341(8842):432. doi: 10.1016/0140-6736(93)93023-t. No abstract available.
- Background: PubMed 15877558Ebihara T, Takahashi H, Ebihara S, Okazaki T, Sasaki T, Watando A, Nemoto M, Sasaki H. Capsaicin troche for swallowing dysfunction in older people. J Am Geriatr Soc. 2005 May;53(5):824-8. doi: 10.1111/j.1532-5415.2005.53261.x.
- Background: PubMed 9349813Caterina MJ, Schumacher MA, Tominaga M, Rosen TA, Levine JD, Julius D. The capsaicin receptor: a heat-activated ion channel in the pain pathway. Nature. 1997 Oct 23;389(6653):816-24. doi: 10.1038/39807.
- Background: PubMed 18629672Hamamoto T, Takumida M, Hirakawa K, Tatsukawa T, Ishibashi T. Localization of transient receptor potential vanilloid (TRPV) in the human larynx. Acta Otolaryngol. 2009 May;129(5):560-8. doi: 10.1080/00016480802273108.
- Background: PubMed 17576907Carnaby-Mann GD, Crary MA. Examining the evidence on neuromuscular electrical stimulation for swallowing: a meta-analysis. Arch Otolaryngol Head Neck Surg. 2007 Jun;133(6):564-71. doi: 10.1001/archotol.133.6.564.
- Background: PubMed 17305276Shaw GY, Sechtem PR, Searl J, Keller K, Rawi TA, Dowdy E. Transcutaneous neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Ann Otol Rhinol Laryngol. 2007 Jan;116(1):36-44. doi: 10.1177/000348940711600107.
- Background: PubMed 19856025Gallas S, Marie JP, Leroi AM, Verin E. Sensory transcutaneous electrical stimulation improves post-stroke dysphagic patients. Dysphagia. 2010 Dec;25(4):291-7. doi: 10.1007/s00455-009-9259-3. Epub 2009 Oct 24.
- Background: PubMed 7640720Logemann JA. Dysphagia: evaluation and treatment. Folia Phoniatr Logop. 1995;47(3):140-64. doi: 10.1159/000266348.
- European Society for Swallowing DisordersLink provided by the sponsor.
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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.
Omar Ortega Fernández, MSc principal investigator
Hospital de Mataró
Pere Clavé, MD, PhD study director
Hospital de Mataró
Laia Rofes, MSc principal investigator
Hospital de Mataró
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical stimulation and TRPV1 agonist in people with Dysphagia, 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 3 inclusion and 9 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 19 Mar 2015. 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.
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?
Oropharyngeal motor response measured by Videofluoroscopy. (time frame: Week 1 and 5.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01762228, which also lists 11 linked publications.
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 19 Mar 2015.