Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07234903

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

Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2026-04-21

12

Participants Needed

2

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 18 and 65 years old at enrollment
  • Have an ASIA Impairment Scale grade of A, B, C, or D
  • Have a spinal cord injury level at T10 or higher with intact anatomy extending 6 cm above the conus tip
  • Have a traumatic spinal cord injury sustained less than 6 weeks ago (subacute) or more than 1 year ago (chronic)
  • Have a stable medical, physical, and psychological condition
  • Have residual upper limb function sufficient for weight bearing support
  • Be able to understand and communicate in German, French, or English
  • Agree to comply with study conditions and attend all appointments
  • Provide informed consent before any study procedures
  • For women of childbearing potential, have an acceptable or highly effective contraception method
Not Eligible

You will not qualify if you...

  • Be pregnant or breastfeeding
  • Have brain damage
  • Have a history of epilepsy
  • Have participated in another clinical study with drugs or devices within the past 30 days
  • Have previously received stem cell injections in the spinal cord
  • Have diseases increasing risks of spinal cord injury surgery
  • Require ventilator support
  • Have contraindications to mobility (such as unhealed fractures or nervous system disorders)
  • Have spinal cord injury from non-traumatic causes (ischemic, tumoral, autoimmune, etc.)
  • Have anatomical limitations at the implantation site (e.g., spinal stenosis, bone damage)
  • Require an intrathecal baclofen pump
  • Have active implanted devices
  • Have conditions preventing participation (e.g., renal failure, liver dysfunction, cardiovascular disease)
  • Be the investigator, family member, employee, or dependent person of the study team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Schweizer Paraplegiker-Zentrum (SPZ)

Nottwil, Canton of Lucerne, Switzerland, 6207

Not Yet Recruiting

2

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

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Research Team

J

Jocelyne Bloch, Prof. Dr. MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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