NCT07234903 ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury
| NCT ID | NCT07234903 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-04 |
| Primary Completion | 2032-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2026-04 with a primary completion date of 2032-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Must be at least 18 years old and no older than 65 years old at the time of enrollment. 2. Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS). 3. 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. 4. 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"). 5. Must be suffering from a SCI due to trauma. 6. Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists. 7. Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration). 8. Must be able to understand and interact with the study team in German, French or English. 9. Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments. 10. Must provide Informed Consent as documented by signature prior to any study-related procedures. 11. Must have an acceptable or highly effective method of contraception for women of childbearing capacity. Exclusion Criteria: 1. Must not be pregnant nor breastfeeding. 2. Must not have brain damage. 3. Must not have a history of epilepsy 4. Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study. 5. Must not have previously been injected with stem cells in the spinal cord. 6. Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery. 7. Must not require ventilator support. 8. Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.). 9. Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.). 10. Must not have any anatomical limitations in the implantation area as judged by the investigators (e.g., spinal stenosis, limiting protrusions, post-traumatic bone damage at area of implantation). 11. Must not require the use of an intrathecal baclofen pump. 12. Must not have any active implanted devices. 13. Must not have any other conditions that would make the subject unable to participate in testing in the judgment of the investigators (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.). 14. Must not be the investigator him/herself, his/her family members, employees or other dependent persons.
Contact & Investigator
Jocelyne Bloch, Prof. Dr. MD
PRINCIPAL INVESTIGATOR
CHUV
Frequently Asked Questions
Who can join the NCT07234903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07234903 currently recruiting?
Yes, NCT07234903 is actively recruiting participants. Contact the research team at jocelyne.bloch@chuv.ch for enrollment information.
Where is the NCT07234903 trial being conducted?
This trial is being conducted at Nottwil, Switzerland, Lausanne, Switzerland.
Who is sponsoring the NCT07234903 clinical trial?
NCT07234903 is sponsored by Ecole Polytechnique Fédérale de Lausanne. The principal investigator is Jocelyne Bloch, Prof. Dr. MD at CHUV. The trial plans to enroll 12 participants.