DysphagiaNCT01345890
Cortical Neuromodulation in Post Stroke Dysphagia
A study testing electrical stimulation in people with Dysphagia, run by University Hospital, Rouen at 1 site in France.
Trial summary
The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Jun 2010
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- post stroke dysphagia
Who cannot join
- contraindication to magnetic stimulation, unability to accept the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation in Post Stroke Dysphagia
The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.
Read the detailed description
Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.
The investigators measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing
- Conditions
- Dysphagia
- Being tested
- electrical stimulation
- Keywords
- swallowing, stroke, aspiration, human, electrical stimulation, post stroke dysphagia
- 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.
electrical stimulationProcedure or surgery
sub motor threshold stimulation of mylohyoid muscles
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation | Experimental | stroke patients Receives: Procedure: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
videofluoroscopy
measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing
Measured: before and after (once a day for 5 consecutive days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionJun 2010
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERIN, MD-PhD, Principal investigator, Rouen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345890
- Sponsor's protocol ID
- 2004/008/HP
- Status last verified
- Jun 2013
- First submitted
- 17 Feb 2009
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation in Post Stroke Dysphagia
- ClinicalTrials.gov ID
- NCT01345890
- Acronym / sponsor ID
- 2004/008/HP
- Conditions
- Dysphagia
- Keywords
- swallowing, stroke, aspiration, human, electrical stimulation, post stroke dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 May 2011 (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.
The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.
Detailed description
Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.
The investigators measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation | Experimental | Procedure: electrical stimulationstroke patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- post stroke dysphagia
Key exclusion criteria (1 listed)
- contraindication to magnetic stimulation, unability to accept the study
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 |
|---|---|---|
| electrical stimulationsub motor threshold stimulation of mylohyoid muscles | Procedure or surgery | electrical stimulation |
Primary outcome
videofluoroscopy
Time frame: before and after (once a day for 5 consecutive days)
measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing
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 18 Jun 2013.
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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, MD-PhD principal investigator
Rouen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation in people with Dysphagia, run by University Hospital, Rouen at 1 site 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 1 inclusion and 1 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 18 Jun 2013. 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 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. 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?
videofluoroscopy (time frame: before and after (once a day for 5 consecutive days)). 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 18 Jun 2013.