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

Ecole Polytechnique Fédérale de Lausanne

Status: Not yet enrolling

Conditions: Chronic Spinal Cord Injury; Subacute Spinal Cord Injury; SCI - Spinal Cord Injury; SCI; Spinal Cord Injury; Spinal Cord Injury (SCI)

Treatments: Device: ARC-IM Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07234903

EIGER

Details and patient eligibility

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Subacute SCI

Experimental group

Description:

Participants having sustained the injury less than 6 weeks prior to baseline (subacute). Participants will be provided with the ARC-IM Therapy.

Treatment:

Device: ARC-IM Therapy

Chronic SCI

Experimental group

Description:

Participants having sustained the injury more than 1 year prior to enrollment (chronic). Participants will be provided with the ARC-IM Therapy.

Treatment:

Device: ARC-IM Therapy