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

N/ANot Yet RecruitingNCT07234903

Ecole Polytechnique Fédérale de Lausanne12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury SCI SCI - Spinal Cord Injury Subacute Spinal Cord Injury Chronic Spinal Cord Injury Spinal Cord Injury (SCI)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to ARC-IM Therapy, from implantation up to the end of the study.

Assess the preliminary safety of ARC-IM Therapy in participants with subacute and chronic SCI.

Time frame: Continuously throughout the study (up to 6 years)

Secondary Outcomes

American Spinal Injury Association (ASIA) International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI)

The ASIA ISNCSCI is a clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury.

Time frame: At Eligibility, and at 6 weeks, 16 weeks, 42 weeks post-surgery

10-Meter Walk Test (10MWT)

The 10MWT assesses walking speed in meters per second over a short duration. It measures the time taken by the subjects to walk 10 meters. The test will be performed twice, at self-selected and at maximum velocity. Participants can use their habitual assistive device. The test will be conducted both with and without stimulation.

Time frame: At Baseline, and at 6 weeks, 16 weeks, ad 42 weeks post-surgery

6-Minute Walk Test (6MWT)

The 6MWT assesses endurance by measuring the distance in meters a participant walks in 6 minutes. Participants can use their habitual assistive device and can take as many standing breaks as they need, but the timer will not be paused. This test will be conducted both with and without stimulation.