UnknownNot Applicable

Robust Intelligent Keyboard for Quadraplegic Patients

France20 participantsStarted 2013-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BIT RATE IN BIT PER MINUTE(bpm)

Timeframe: 15 MINUTES

Trial details

NCT IDNCT01707498

SponsorCentre d'Investigation Clinique et Technologique 805

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01

Contact for this trial

DAVID ORLIKOWSKI, MD PHD

david.orlikowski@rpc.aphp.fr

View on ClinicalTrials.gov More Quadraplegia trials