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.
Parallel
ARC-IM Therapy
DeviceAll participants will be treated with ARC-IM Therapy. The ARC-IM Lumbar System is intended to deliver electrical impulses to the lumbosacral region of the spinal cord to support ambulatory functions in people with SCI.
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to ARC-IM Therapy, from implantation up to the end of the study.
Assess the preliminary safety of ARC-IM Therapy in participants with subacute and chronic SCI.
American Spinal Injury Association (ASIA) International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI)
The ASIA ISNCSCI is a clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.
10-Meter Walk Test (10MWT)
The 10MWT assesses walking speed in meters per second over a short duration. It measures the time taken by the subjects to walk 10 meters. The test will be performed twice, at self-selected and at maximum velocity. Participants can use their habitual assistive device. The test will be conducted both with and without stimulation.
6-Minute Walk Test (6MWT)
The 6MWT assesses endurance by measuring the distance in meters a participant walks in 6 minutes. Participants can use their habitual assistive device and can take as many standing breaks as they need, but the timer will not be paused. This test will be conducted both with and without stimulation.
Timed Up and Go (TUG)
The TUG evaluates functional mobility. Participants begin seated, then stand up, walk 3 meters, turn around, walk back, and sit down. The time taken to complete the sequence is recorded. Assistive devices may be used if necessary. The test will be conducted both with and without stimulation.
ARC-IM stimulation usage log
Independent use of the ARC-IM Lumbar System by study participants will be evaluated through analysis of the ARC-IM stimulation usage log.
Integration of ARC-IM Therapy within the standard-of-care
Integration of ARC-IM Therapy within the standard-of-care for subacute SCI will be evaluated by quantifying its use within standard clinical mobility rehabilitation procedures. This will be achieved by extracting and comparing data of the Stimulation Usage Log and Participant's Calendar Log.
EES Evoked Muscle Response
Effect of ARC-IM Therapy on the modulation of the spinal cord will be evaluated through electrophysiological assessments that will quantify the muscle responses to EES and adaptation of these responses over time.
Function In Sitting Test for Spinal Cord Injury (FIST-SCI)
Effect of ARC-IM Therapy on trunk stability will be evaluated using the FIST-SCI. The FIST-SCI assesses sitting balance. It evaluates sensory, motor, proactive, reactive, and steady state balance factors based on 14 items, each scored on an ordinal scale from 0 to 4, where 0 means complete assistance is needed to perform the task successfully, and 4 means can complete the task independently and successfully. The test will be conducted both with and without stimulation.
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
