NCT01707498

Brief Summary

This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 5, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

October 5, 2012

Last Update Submit

January 31, 2018

Conditions

Quadraplegia

Keywords

BCITETRAPLEGIACOMMUNICATIONP300ASSISTIVE TECHNOLOGIE

Outcome Measures

Primary Outcomes (1)

  • BIT RATE IN BIT PER MINUTE(bpm)

    Bitrate (bpm): transfer of information from patient to computer in bits per minutes. This is a reference measurement to compare P300 speller Brain Computer Interfaces. It uses: number of choices on the interface (N), the average time to select one key (t) and the error rate (e)

    15 MINUTES

Secondary Outcomes (1)

  • Installation time (seconds)

    60 mns

Study Arms (2)

Tetraplegic patients

EXPERIMENTAL

Scanning device RoBIK Brain-Computer Interface

Procedure: Scanning deviceProcedure: RoBIK Brain-Computer Interface

Healthy volunteers

EXPERIMENTAL

RoBIK Brain-Computer Interface

Procedure: RoBIK Brain-Computer Interface

Interventions

Scanning devicePROCEDURE

Patients will be asked to spell a text with a specific scanning device. The most appropriate contactor or clicking device will be chosen by a senior therapist.

Tetraplegic patients
RoBIK Brain-Computer InterfacePROCEDURE

Patients will be asked to spell a text with the BCI

Healthy volunteersTetraplegic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers:
  • Informed consent
  • Adults aged more than 18yo
  • Passed complete medical check-up (heart-rate, blood pressure,...)
  • Negative pregnancy test
  • Quadripleagic patients:
  • Informed consent
  • Adults aged more than 18years
  • Passed medical exam
  • Negative pregnancy test
  • Full medical checkup
  • haemodynamic stability

You may not qualify if:

  • Healthy volunteers:
  • history of epilepsy or seizure
  • auditory or visual deficit
  • atopic scalp dermatitis
  • hypersensitivity to gold
  • curator/guardianship/under protection of judicial authority
  • unable to understand the information note and/or to cooperate
  • no social security
  • can't read
  • Quadripleagic patients:
  • history of epilepsy or seizure
  • auditory or visual deficit
  • cerebral lesion
  • atopic scalp dermatitis
  • hypersensitivity to gold
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

QuadriplegiaCommunication

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • LOUIS MAYAUD, ENGINEER

    CIC IT 805

    STUDY DIRECTOR

Central Study Contacts

DAVID ORLIKOWSKI, MD PHD

CONTACT

david.orlikowski@rpc.aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 16, 2012

Study Start

February 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

FR(1)