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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Universitaire Vaudois (CHUV)
  Lausanne, Canton of Vaud, Switzerland Recruiting
• Schweizer Paraplegiker-Zentrum (SPZ)
  Nottwil, Canton of Lucerne, Switzerland Not yet recruiting

Study contacts

• Principal investigator: Jocelyne Bloch, Prof. Dr. MD — Chuv
• Study coordinator: Jocelyne Bloch, Prof. Dr. MD
• Email: jocelyne.bloch@chuv.ch
• Phone: +41 79 556 29 51

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.