The EIGER study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support and promote recovery of ambulatory functions, such as walking, in people with subacute and chronic spinal cord injury.
Must be at least 18 years old and no older than 65 years old at the time of enrollment.
Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS).
Must have a SCI level at T10 or higher as determined by ISNCSCI, with the region extending 6 cm above the tip of the conus remaining anatomically intact as determined by MRI.
Must have sustained their injury either less than 6 weeks prior to baseline (Group "Subacute SCI"), or more than 1 year prior to enrollment (Group "Chronic SCI").
Must not be pregnant nor breastfeeding.
Must not have brain damage.
Must not have a history of epilepsy
Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study.
Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution