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

This study is currently recruiting participants.

Verified by University Hospital, Grenoble, January 2007

Sponsors and Collaborators:	University Hospital, Grenoble Centre Medico Universitaire Daniel Douady (CMUDD) GMCAO team of TIMC-IMAG-CNRS laboratory
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00429013

Purpose

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	Intervention	Phase
Paraplegia	Device: Tongue Display Unit	Phase II

MedlinePlus related topics: Pressure Sores

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomised, Controlled, Open Study. Phase II Treatment Equivalent.

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

Difference of adapted movement (in term of pressure) between the A and B groups.

Secondary Outcome Measures:

Qualitative and quantitative knowledge evaluation
Qualitative medical device evaluation
Adverse event collection

Estimated Enrollment:	24
Study Start Date:	September 2006
Estimated Study Completion Date:	April 2007

Detailed Description:

The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by an 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429013

Contacts

Contact: Alexandre Moreau-Gaudry, Ph.D M.D.

33476765040

Alexandre.Moreau-Gaudry@imag.fr

Locations

France, CEDEX 09
University Hospital of Grenoble	Recruiting
GRENOBLE, CEDEX 09, France, 38043
Sub-Investigator: Anne Prince, M.D.
Sub-Investigator: Thomas Fortin, M.D. Ph.D.
Sub-Investigator: Marc Hommel, M.D.
Sub-Investigator: Wilfried Vadot, M.D.

Sponsors and Collaborators

University Hospital, Grenoble

Centre Medico Universitaire Daniel Douady (CMUDD)

GMCAO team of TIMC-IMAG-CNRS laboratory

Investigators

Principal Investigator:

Alexandre Moreau-Gaudry, Ph.D. M.D.

University Hospital, Grenoble

More Information

First works on sensory substitution This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	DCIC-05-44
Study First Received:	January 29, 2007
Last Updated:	January 29, 2007
ClinicalTrials.gov Identifier:	NCT00429013
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

Pressure ulcer
Lingual electric stimulation
Paraplegic patient
Pressure Ulcer/Prevention & control

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Skin Diseases
Ulcer

Paraplegia
Neurologic Manifestations
Skin Ulcer
Pressure Ulcer

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009