NCT01005524

Brief Summary

The main objective of this study is to evaluate the usability of a system to assist verbal communication based on BCI system using the P300 wave in patients with tetraplegia who can no longer communicate because of severe engine damage (tetraplegia) and respiratory damage requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal communication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

October 30, 2009

Last Update Submit

May 21, 2012

Conditions

TetraplegiaGuillain-Barre Syndrome

Keywords

brain computer interfaceP3SpellerP300Event Related potentialtetraplegiaGuillain barre syndromeFeasibilitySpeed of spellingAccuracy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Quadriplegia, also known as tetraplegia, is paralysis caused by illness or injury to a human that results in the partial or total loss of use of all of their limbs and torso; paraplegia is similar but does not affect the arms. The loss is usually sensory and motor, which means both sensation and control are lost.

You may qualify if:

  • Admitted in the ICU
  • Quadriplegic and requiring mechanical ventilation (tracheostomy) 24/24h

You may not qualify if:

  • Acute respiratory failure.
  • Visual disorder
  • Cognitive disorder
  • Illiterate patient
  • Mother tongue other than french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de reanimation, Hopital Raymond Poincare

Garches, 92380, France

Location

Related Links

MeSH Terms

Conditions

QuadriplegiaGuillain-Barre Syndrome

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of ICU

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

FR(1)