ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury

Sponsor
Ecole Polytechnique Fédérale de Lausanne
Study ID
NCT07234903
Status
Recruiting
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Conditions

  • Chronic Spinal Cord Injury
  • SCI
  • SCI - Spinal Cord Injury
  • Spinal Cord Injury
  • Spinal Cord Injury (SCI)
  • Subacute Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ARC-IM Therapy — DEVICE
    All 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.

Study Details

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.

Key Dates

First listed
Nov 19, 2025
Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2032
Completion
Apr 30, 2032

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Subacute SCI
    Participants having sustained the injury less than 6 weeks prior to baseline (subacute). Participants will be provided with the ARC-IM Therapy.
  • Experimental: Chronic SCI
    Participants having sustained the injury more than 1 year prior to enrollment (chronic). Participants will be provided with the ARC-IM Therapy.

Primary Outcome Measure

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. [ Time Frame: Continuously throughout the study (up to 6 years) ]

Central Contacts

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