Using a brain-computer interface to control a motorized exoskeleton for people with severe spinal injuries
Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton
This study is testing whether a brain-computer interface can help people with severe spinal injuries move again using a motorized exoskeleton.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT02550522 on ClinicalTrials.gov |
What this trial studies
This project explores the use of a brain-computer interface (BCI) to help individuals with traumatic tetraplegia regain mobility through a motorized exoskeleton. The BCI system involves implanting devices that record brain activity via an electrocorticogram (ECoG), which is then used to control the exoskeleton. The goal is to provide a means of compensation for motor deficits caused by cervical spinal cord injuries, ultimately improving the quality of life for affected individuals. Participants will be closely monitored to assess the effectiveness and safety of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 45 with stable neurological deficits from cervical spinal cord injuries who express a need for improved mobility.
Not a fit: Patients with previous brain surgery, significant neuropsychological issues, or those with substance dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance mobility and independence for patients with severe spinal cord injuries.
How similar studies have performed: While the use of brain-computer interfaces is a growing field, this specific application with a motorized exoskeleton is innovative and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Grenoble
- Clinatec — Grenoble, France (Recruiting)
Study contacts
- Study coordinator: Stéphan CHABARDES, MD, PhD
- Email: SChabardes@chu-grenoble.fr
- Phone: + 33 4 76 76 75 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.