ARC-IM therapy to help restore walking after spinal cord injury

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

This study will try ARC-IM Therapy (epidural electrical stimulation) in adults with subacute or chronic traumatic spinal cord injury to see if it helps improve walking and other ambulatory functions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ecole Polytechnique Fédérale de Lausanne (Academic / other)
• Locations: 2 sites (Nottwil, Canton of Lucerne and 1 other locations)
• Trial ID: NCT07234903 on ClinicalTrials.gov

What this trial studies

ARC-IM Therapy uses epidural electrical stimulation applied to the lower spinal cord to support neural circuits involved in standing and stepping. In this interventional study, adults with traumatic subacute (<6 weeks) or chronic (>1 year) spinal cord injury at T10 or above will receive ARC-IM Therapy and be monitored for safety and preliminary changes in walking and related functions. Eligible participants must meet ASIA Impairment Scale A–D criteria, have residual upper-limb function for weight-bearing, and be able to communicate in German, French, or English. Clinical visits at the Schweizer Paraplegiker-Zentrum (Nottwil) and CHUV (Lausanne) will include imaging, functional testing, and follow-up safety and performance assessments.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with a traumatic spinal cord injury at T10 or above (subacute <6 weeks or chronic >1 year), ASIA A–D, who retain enough arm function for weight-bearing and can communicate in German, French, or English.

Not a fit: People with non‑traumatic injuries, injuries below T10 or with major anatomical disruption of the target spinal segment, those older than 65, medically unstable patients, or those without sufficient upper‑limb support or required language ability are unlikely to match or benefit.

Why it matters

Potential benefit: If successful, ARC-IM Therapy could improve walking, standing, and daily independence for people with traumatic subacute or chronic spinal cord injury.

How similar studies have performed: Previous research with epidural electrical stimulation has shown promising improvements in voluntary movement and stepping in some people with SCI, although devices and protocols have differed and results are variable.

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.

Where this trial is running

Nottwil, Canton of Lucerne and 1 other locations

• Schweizer Paraplegiker-Zentrum (SPZ) — Nottwil, Canton of Lucerne, Switzerland (Not_yet_recruiting)
• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)

Study contacts

• Principal investigator: Jocelyne Bloch, Prof. Dr. MD — Chuv
• Study coordinator: Jocelyne Bloch, Prof. Dr. MD

Conditions Spinal Cord Injury; SCI; SCI - Spinal Cord Injury; Subacute Spinal Cord Injury; Chronic Spinal Cord Injury; Epidural Electrical Stimulation; Spinal Cord Stimulation; ARC-IM Therapy