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Recruiting NCT02550522

NCT02550522 Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton

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Clinical Trial Summary
NCT ID NCT02550522
Status Recruiting
Phase
Sponsor University Hospital, Grenoble
Condition Traumatic Tetraplegia with Cervical Cord Injury
Study Type INTERVENTIONAL
Enrollment 5 participants
Start Date 2015-09
Primary Completion 2033-04

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 55 Years
Study Type INTERVENTIONAL
Interventions
Brain-computer interface (BCI) platform including two implanted remotely powered ElectroCorticoGraph (ECoG) recording devices and an exoskeleton

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 5 participants in total. It began in 2015-09 with a primary completion date of 2033-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The BCI project falls within the very broad field of brain machine interfaces. Its multiple applications include the compensation of motor deficits. The subject of the present protocol is the first test of the system in man on the compensation of motor deficits by an epidural brain implant enabling an electrocorticogram (EcoG) to be recorded.

Eligibility Criteria

Inclusion Criteria: * Male or female aged between 18 and 45 years * Stability of neurological deficits in accrued sequelae * Lack of adequate compensation for the deficits in terms of quality of life. In other words, the expression by the patient of a need for additional mobility, oriented towards greater autonomy * Ambulatory or hospitalized monitoring * Fluent in French and able to understand the study procedures, including completing the auto-questionnaires * Registered in the French social security scheme * Signed informed consent of the patient will be collected before inclusion in the study Exclusion Criteria: * Previous brain surgery, * Chronic prescription of anticoagulant treatments, * Impaired neuropsychological sequelae from an associated head injury, * Depressive syndrome with or without suicide attempt. * Alcohol or other substance dependence in the last 12 months, with abuse in the - A complete assessment (neurological and neuropsychological) will be conducted among eligible patients. * Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG) * Contraindication to Magnetic resonance imaging (MRI)

Contact & Investigator

Central Contact

Stéphan CHABARDES, MD, PhD

✉ SChabardes@chu-grenoble.fr

📞 + 33 4 76 76 75 59

Frequently Asked Questions

Who can join the NCT02550522 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Traumatic Tetraplegia with Cervical Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT02550522 currently recruiting?

Yes, NCT02550522 is actively recruiting participants. Contact the research team at SChabardes@chu-grenoble.fr for enrollment information.

Where is the NCT02550522 trial being conducted?

This trial is being conducted at Grenoble, France.

Who is sponsoring the NCT02550522 clinical trial?

NCT02550522 is sponsored by University Hospital, Grenoble. The trial plans to enroll 5 participants.

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