PARAPLEGIAPhase 2NCT00429013
Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.
A Phase 2 study testing Tongue Display Unit in people with PARAPLEGIA, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARAPLEGIA
- What is being tested?
- Tongue Display Unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient affiliated to social security or similarly regime
- paraplegic medullary patient
- more or equal than 18 years old.
Who cannot join
- patients will be excluded if at least one of the following criteria is present :
- pregnancy and feeding women
- persons without liberty by administrative or judiciary decision
- persons hospitalized without consent
- persons concerned by a justice protection action
- dependant major person
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- palatine prosthesis intolerance
- buttock pressure ulcer evolution
- acute pathology (particularly mouth level)
- nickel allergy
- impossibility to use the medical device, to understand or realize the protocol due to cognitive pathologies.
- patient with dental troubles incompatible with the realisation or utilisation of orthodontic prothesis.
- no tactile feeling with tongue,
- impossibility to set up the orthodontic prothesis due to superior limb deterioration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.
Will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.
Read the detailed description
The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by a lingual electric stimulation.
Two A and B study groups of paraplegic subjects will be built-up in a randomized way. Under standardized conditions, the A study group subject will modify his usual behavior by using the cosmetically acceptable interface to get back information for moving his chest in a suitable way in order to correct identified maxima of pressure at the seat/skin interface. Under the same conditions but without the developed device, the B study group subject will have an usual behavior.
The analysis of the different behavior in these two groups will enable to evaluate, in an objective way, the potential interest of this new medical device for the prevention of pressure ulcer.
- Conditions
- PARAPLEGIA
- Being tested
- Tongue Display Unit
- Keywords
- Pressure ulcer, Lingual electric stimulation, Paraplegic patient, Pressure Ulcer/Prevention & control
- Medical subject headings
- Paraplegia, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongue Display UnitDevice
lingual electric stimulation
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | no medical device |
| 1 | Experimental | medical device Receives: Device: Tongue Display Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of adapted movement (in term of pressure) between the A and B groups.
Measured: 3 weeks
Secondary outcomes (3)
Qualitative and quantitative knowledge evaluation
Measured: 3 weeks
Qualitative medical device evaluation
Measured: 3 weeks
Adverse event collection
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startSep 2006
- Primary completionJan 2009
- Study completionMar 2009
Why it stopped: principal criteria was achieved with the intermediate statistical analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PARAPLEGIAStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Medico Universitaire Daniel Douady (CMUDD), TIMC-IMAG
- Responsible party
- Sponsor
- Investigators
- Alexandre Moreau-Gaudry, Ph.D. M.D., Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429013
- Sponsor's protocol ID
- DCIC-05-44
- Status last verified
- Sep 2016
- First submitted
- 29 Jan 2007
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moreau-Gaudry A, Prince A, Demongeot J, Payan Y. A new health strategy to prevent pressure ulcer formation in paraplegics using computer and sensory substitution via the tongue. Stud Health Technol Inform. 2006;124:926-31.
PubMed 17108630
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.
- ClinicalTrials.gov ID
- NCT00429013
- Acronym / sponsor ID
- DCIC-05-44
- Conditions
- PARAPLEGIA
- Keywords
- Pressure ulcer, Lingual electric stimulation, Paraplegic patient, Pressure Ulcer/Prevention & control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: principal criteria was achieved with the intermediate statistical analysis
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Centre Medico Universitaire Daniel Douady (CMUDD), TIMC-IMAG
- Study start
- Sep 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Jan 2007 (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.
Will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.
Detailed description
The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by a lingual electric stimulation.
Two A and B study groups of paraplegic subjects will be built-up in a randomized way. Under standardized conditions, the A study group subject will modify his usual behavior by using the cosmetically acceptable interface to get back information for moving his chest in a suitable way in order to correct identified maxima of pressure at the seat/skin interface. Under the same conditions but without the developed device, the B study group subject will have an usual behavior.
The analysis of the different behavior in these two groups will enable to evaluate, in an objective way, the potential interest of this new medical device for the prevention of pressure ulcer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –no medical device |
| 1 | Experimental | Device: Tongue Display Unitmedical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient affiliated to social security or similarly regime
- paraplegic medullary patient
- more or equal than 18 years old.
Key exclusion criteria (14 listed)
- pregnancy and feeding women
- persons without liberty by administrative or judiciary decision
- persons hospitalized without consent
- persons concerned by a justice protection action
- dependant major person
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 |
|---|---|---|
| Tongue Display Unitlingual electric stimulation | Device | 1 |
Primary outcome
Difference of adapted movement (in term of pressure) between the A and B groups.
Time frame: 3 weeks
3 secondary outcomes
Qualitative and quantitative knowledge evaluation
Time frame: 3 weeks
Qualitative medical device evaluation
Time frame: 3 weeks
Adverse event collection
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: principal criteria was achieved with the intermediate statistical analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Background: PubMed 17108630Moreau-Gaudry A, Prince A, Demongeot J, Payan Y. A new health strategy to prevent pressure ulcer formation in paraplegics using computer and sensory substitution via the tongue. Stud Health Technol Inform. 2006;124:926-31.
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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.
Alexandre Moreau-Gaudry, Ph.D. M.D. principal investigator
University Hospital, Grenoble
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 Tongue Display Unit in people with PARAPLEGIA, run by University Hospital, Grenoble 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 3 inclusion and 14 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 15 Sep 2016. 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.
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 was stopped early (reason given: principal criteria was achieved with the intermediate statistical analysis). 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?
Difference of adapted movement (in term of pressure) between the A and B groups. (time frame: 3 weeks). 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 NCT00429013, which also lists 1 linked publication.
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 15 Sep 2016.