ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute an… (NCT07234903) | Clinical Trial Compass
RecruitingNot Applicable
ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury
Switzerland12 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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 be suffering from a SCI due to trauma.
✓. Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists.
✓. Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration).
✓. Must be able to understand and interact with the study team in German, French or English.
Exclusion criteria
✕. 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.
What they're measuring
1
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.
Timeframe: Continuously throughout the study (up to 6 years)
✕. Must not have previously been injected with stem cells in the spinal cord.
✕. Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery.
✕. Must not require ventilator support.
✕. Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.).