ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01707498
Date of registration:	05/10/2012
Prospective Registration:	Yes
Primary sponsor:	Centre d'Investigation Clinique et Technologique 805
Public title:	Robust Intelligent Keyboard for Quadraplegic Patients PVCRoBIK
Scientific title:	Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
Date of first enrolment:	February 2013
Target sample size:	20
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT01707498
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	LOUIS MAYAUD, ENGINEER
Address:
Telephone:
Email:
Affiliation:	CIC IT 805

Name:	DAVID ORLIKOWSKI, MD PHD
Address:
Telephone:
Email:	david.orlikowski@rpc.aphp.fr
Affiliation:

Name:	DAVID ORLIKOWSKI, MD PHD
Address:
Telephone:	(33)147107777
Email:	david.orlikowski@rpc.aphp.fr
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

- curator/guardianship/under protection of judicial authority

- unable to understand the information note and/or to cooperate

- no social security

- can't read

- included in a different clinical trial with exclusion period

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Quadraplegia

Intervention(s)

Procedure: RoBIK Brain-Computer Interface

Procedure: Scanning device

Primary Outcome(s)

BIT RATE IN BIT PER MINUTE(bpm) [Time Frame: 15 MINUTES]

Secondary Outcome(s)

Installation time (seconds) [Time Frame: 60 mns]

Secondary ID(s)

2012-A00613-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Versailles

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.