Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00429013
Recruitment Status : Terminated (principal criteria was achieved with the intermediate statistical analysis)
First Posted : January 30, 2007
Last Update Posted : September 15, 2016
Centre Medico Universitaire Daniel Douady (CMUDD)
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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 matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.

Condition or disease Intervention/treatment Phase
PARAPLEGIA Device: Tongue Display Unit Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.
Study Start Date : September 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 2
no medical device
Experimental: 1
medical device
Device: Tongue Display Unit
lingual electric stimulation

Primary Outcome Measures :
  1. Difference of adapted movement (in term of pressure) between the A and B groups. [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Qualitative and quantitative knowledge evaluation [ Time Frame: 3 weeks ]
  2. Qualitative medical device evaluation [ Time Frame: 3 weeks ]
  3. Adverse event collection [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient affiliated to social security or similarly regime
  • paraplegic medullary patient
  • more or equal than 18 years old.

Exclusion Criteria:

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00429013

University Hospital of Grenoble
Grenoble, Cedex 09, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Centre Medico Universitaire Daniel Douady (CMUDD)
Principal Investigator: Alexandre Moreau-Gaudry, Ph.D. M.D. University Hospital, Grenoble

Additional Information:
Responsible Party: University Hospital, Grenoble Identifier: NCT00429013     History of Changes
Other Study ID Numbers: DCIC-05-44
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Keywords provided by University Hospital, Grenoble:
Pressure ulcer
Lingual electric stimulation
Paraplegic patient
Pressure Ulcer/Prevention & control

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms