Oropharyngeal DysphagiaPhase 3TENSDEGNCT01971320
Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
A Phase 3 study testing Urostim I stimulation in people with Oropharyngeal Dysphagia and Deglutition Disorders, run by University Hospital, Rouen at 6 sites in France.
Trial summary
Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Oropharyngeal Dysphagia, Deglutition Disorders
- What is being tested?
- Urostim I stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 6 sitesFrance
- Study dates
- Jun 2014to May 2016
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years
- No contraindication to electrical stimulation
- Oropharyngeal dysphagia from 8 weeks diagnosed by videofluorosocpy with penetration aspiration scale > 3 or a residue ≥ 50%
- Due to an hemispheric stroke
- Patients able to understand the videofluroscopy and questionnaires
- For women in age of procreation, to have a contraception, a pregnacy test will be done if not
- Able to swallow (a nasogastric tube is not a contraindication to participate)
Who cannot join
- Pregnancy or breast feeding
- Psychiatric illnes
- Swallowing disorders before the stroke
- Contraindication to electrical stimulation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre les Herbiers
Bois-Guillaume
UH Bordeaux
Bordeaux
UH Limoges
Limoges
AP-HP Fernand WIDAL
Paris
UH Rouen
Rouen
UH Toulouse
Toulouse
About this study
Oropharyngeal dysphagia induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. This technique could be used at home.
The aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. Sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. It will be administrated via surface electrodes over the hyoid bone. Patients will be separated by randomisation.
Read more
Patients will be evaluated before and after 6 weeks of use. Methods will evaluation questionnaire, clinical examination and videofluoroscopy. The time of use will also be collected.
We wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.
- Conditions
- Oropharyngeal Dysphagia, Deglutition Disorders
- Being tested
- Urostim I stimulation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urostim I stimulationDevice
Urostim I stimulation will be done during meals for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| active stimulation | Experimental | sensitive electrical stimulation applied during meals with Urostim I for 6 weeks
Urostim I stimulation will be done during meals for 6 weeks Receives: Device: Urostim I stimulation |
| fake stimulation | Placebo comparator | Urostim I stimulation will be done during meals for 6 weeks
Fake sensitive electrical stimulation applied during meals with modified Urostim I who not deliver stimulation for 6 weeks Receives: Device: Urostim I stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of oropharyngeal dysphagia symptoms
Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)
Measured: Week 6
Secondary outcomes (1)
Evaluation of oropharyngeal dysphagia symptoms
Evaluation of oropharyngeal dysphagia symptoms by videofluoroscopy and Swal-QoL questionnaire
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERIN, Professor, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971320
- Sponsor's protocol ID
- 2013/002/HP
- Acronym
- TENSDEG
- Status last verified
- Aug 2016
- First submitted
- 23 Oct 2013
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia
- ClinicalTrials.gov ID
- NCT01971320
- Acronym / sponsor ID
- TENSDEG / 2013/002/HP
- Conditions
- Oropharyngeal Dysphagia, Deglutition Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Oct 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 induces aspirations which could be responsible of aspiration pneumonia and denutrition. It could be present in the majority of central neurological disease (degenerative or vascular disease), which explains that it is the first case of mortality in stroke. Two pilot studies realised by our research group aimed to demonstrate that sensitive transcutaneous electrical stimulation could improve swallowing coordination and reduce aspirations. This technique could be used at home.
The aim of this study is to demonstrate that sensitive electrical stimulation could improve oropharyngeal dysphagia in hemispheric stroke patients. 118 patients should be included in seven centers. Sensitive electrical stimulation will be applied either as active stimulation, either as a placebo. Active electrical stimulation will be realised at 80 hz during 30 minutes, under motor threshold and above sensitive threshold. It will be administrated via surface electrodes over the hyoid bone. Patients will be separated by randomisation.
Patients will be evaluated before and after 6 weeks of use. Methods will evaluation questionnaire, clinical examination and videofluoroscopy. The time of use will also be collected.
We wish to demonstrate that transcutaneous electrical stimulation is able to improve oropharyngeal dysphagia in stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Experimental | Device: Urostim I stimulationsensitive electrical stimulation applied during meals with Urostim I for 6 weeks Urostim I stimulation will be done during meals for 6 weeks |
| fake stimulation | Placebo comparator | Device: Urostim I stimulationUrostim I stimulation will be done during meals for 6 weeks Fake sensitive electrical stimulation applied during meals with modified Urostim I who not deliver stimulation for 6 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 85 years
- No contraindication to electrical stimulation
- Oropharyngeal dysphagia from 8 weeks diagnosed by videofluorosocpy with penetration aspiration scale > 3 or a residue ≥ 50%
- Due to an hemispheric stroke
- Patients able to understand the videofluroscopy and questionnaires
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding
- Psychiatric illnes
- Swallowing disorders before the stroke
- Contraindication to electrical stimulation
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 |
|---|---|---|
| Urostim I stimulationUrostim I stimulation will be done during meals for 6 weeks | Device | active stimulation, fake stimulation |
Primary outcome
Evaluation of oropharyngeal dysphagia symptoms
Time frame: Week 6
Evaluation of oropharyngeal dysphagia symptoms by questionnaire (dysphagia handicap index)
1 secondary outcome
Evaluation of oropharyngeal dysphagia symptoms
Time frame: Week 6
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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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.
Eric VERIN, Professor principal investigator
UH Rouen
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Urostim I stimulation in people with Oropharyngeal Dysphagia and Deglutition Disorders, run by University Hospital, Rouen at 6 sites in France.
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 7 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: stopped early, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Evaluation of oropharyngeal dysphagia symptoms (time frame: Week 6). 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 17 Aug 2016.