Oropharyngeal DysphagiarTMSvideoSSNCT02170454
Effect of Pharyngeal Inhibition by rTMS on Swallowing Function
A study testing magnetic stimulation in people with Oropharyngeal Dysphagia, run by University Hospital, Rouen at 1 site in France.
Trial summary
The aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to Jun 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years old
- healthy subjects
Who cannot join
- epilepsia
- brain injury
- stroke
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pharyngeal Cortical Area Inhibition Induced by rTMS on Swallowing Function in Healthy Subject: Video Fluoroscopic Study.
The aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination.
Read the detailed description
The aim of the study is to demonstrate that rTMS (on the dominant hemisphere, on the nondominant hemisphere and placebo rTMS) are able to modify swallowing coordination on healthy subjects. Swallowing function will be studied before and after rTMS with videomanometry.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- magnetic stimulation
- Keywords
- neuromodulation, swallowing, magnetic stimulation, healthy subjects
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic stimulationProcedure or surgery
rTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Active comparator | rTMS on pharyngeal cortical area in healthy subjects Receives: Procedure: magnetic stimulation |
| Placebo | Placebo comparator | Sham rTMS on pharyngeal cortical area in healthy subjects Receives: Procedure: magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharyngeal pressure
Swallowing function will be studied before and after rTMS with videomanometry
Measured: Day 1
Secondary outcomes (1)
swallowing time
Swallowing function will be studied before and after rTMS with videomanometry
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionJun 2009
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERIN, MDPhD, Principal investigator, Rouen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170454
- Sponsor's protocol ID
- 2007/055/HP
- Acronym
- rTMSvideoSS
- Status last verified
- Jun 2014
- First submitted
- 17 Feb 2009
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pharyngeal Cortical Area Inhibition Induced by rTMS on Swallowing Function in Healthy Subject: Video Fluoroscopic Study.
- ClinicalTrials.gov ID
- NCT02170454
- Acronym / sponsor ID
- rTMSvideoSS / 2007/055/HP
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- neuromodulation, swallowing, magnetic stimulation, healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Jun 2014 (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 aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination.
Detailed description
The aim of the study is to demonstrate that rTMS (on the dominant hemisphere, on the nondominant hemisphere and placebo rTMS) are able to modify swallowing coordination on healthy subjects. Swallowing function will be studied before and after rTMS with videomanometry.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Active comparator | Procedure: magnetic stimulationrTMS on pharyngeal cortical area in healthy subjects |
| Placebo | Placebo comparator | Procedure: magnetic stimulationSham rTMS on pharyngeal cortical area in healthy subjects |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-50 years old
- healthy subjects
Key exclusion criteria (4 listed)
- epilepsia
- brain injury
- stroke
- pregnancy
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 |
|---|---|---|
| magnetic stimulationrTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects | Procedure or surgery | Placebo, rTMS |
Primary outcome
pharyngeal pressure
Time frame: Day 1
Swallowing function will be studied before and after rTMS with videomanometry
1 secondary outcome
swallowing time
Time frame: Day 1
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 23 Jun 2014.
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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, MDPhD 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 magnetic stimulation in people with Oropharyngeal 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 2 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 23 Jun 2014. 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. 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.
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 pressure (time frame: Day 1). 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 23 Jun 2014.