Chronic Spinal Cord Injury, SCI, SCI - Spinal Cord Injury, Spinal Cord Injury, Spinal Cord Injury (SCI), Subacute Spinal Cord Injury
Conditions
Keywords
SCI, Spinal Cord Injury, Epidural Electrical Stimulation, Spinal Cord Stimulation, ARC-IM Therapy
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.
Interventions
DEVICEARC-IM Therapy
All participants will be treated with ARC-IM Therapy. The ARC-IM Lumbar System is intended to deliver electrical impulses to the lumbosacral region of the spinal cord to support ambulatory functions in people with SCI.
Sponsors
Ecole Polytechnique Fédérale de Lausanne
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentric, two-arms, non-blinded, non-randomized, interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Continuously throughout the study (up to 6 years) | Assess the preliminary safety of ARC-IM Therapy in participants with subacute and chronic SCI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Spinal Injury Association (ASIA) International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) | At Eligibility, and at 6 weeks, 16 weeks, 42 weeks post-surgery | The ASIA ISNCSCI is a clinical examination used to assess the motor and sensory impairment and severity of a spinal cord injury. |
| 10-Meter Walk Test (10MWT) | At Baseline, and at 6 weeks, 16 weeks, ad 42 weeks post-surgery | 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. |
| 6-Minute Walk Test (6MWT) | At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery | 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. |
| Timed Up and Go (TUG) | At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery | The TUG evaluates functional mobility. Participants begin seated, then stand up, walk 3 meters, turn around, walk back, and sit down. The time taken to complete the sequence is recorded. Assistive devices may be used if necessary. The test will be conducted both with and without stimulation. |
| Walking Index for Spinal Cord Injury version II (WISCI II) | At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery | The WISCI II assesses the extent and nature of assistance a person with SCI requires to walk, using an ordinal scale of 20 levels, ranging from the most severe impairment (level 0) to the least severe impairment (level 20). The level is determined based on the use of assistive devices, braces, and the physical assistance of one or more persons. The test will be conducted both with and without stimulation. |
| Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) | At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery | The SCI-FAI assesses functional walking ability. It is an observational gait assessment that includes 3 key domains of walking function, where 0 is the minimum and worst outcome: gait parameters (maximum score of 20 points), assistive device (each limb scored individually - maximum score of 14 points), and temporal distance (maximum score of 5 points). The test will be conducted both with and without stimulation. |
| Gait Analysis | At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery | Multifactorial gait analysis that relies on high-precision recordings of whole-body kinematics and kinetics of each gait cycle will be performed. The test will be conducted both with and without stimulation. |
| Goal Attainment Scale (GAS) | At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery | The GAS is used to evaluate the participant's progress toward one or more personalized goal(s), which are individually defined by the participant. Each goal is scored on a standardized scale ranging from -2 (outcome is much less than expected) to +2 (outcome is much more than expected), allowing to assess to which extent the goal is met. The form will be completed for both with and without stimulation condition. |
| Berg Balance Scale (BBS) | At Baseline, and at 6 weeks, 16 weeks, 42 weeks post-surgery | The BBS assesses static and dynamic balance through 14 tasks, such as standing, reaching, and turning. Each item is scored on a 5-point scale (0-4) with higher scores meaning better ability to perform the assessed activity. Item scores are then summed, with a maximum score of 56. The use of assistive devices is not allowed. The test will be conducted both with and without stimulation. |
Countries
Switzerland
Contacts
CONTACTJocelyne Bloch, Prof. Dr. MD
PRINCIPAL_INVESTIGATORJocelyne Bloch, Prof. Dr. MD
CHUV
PRINCIPAL_INVESTIGATORBjörn Zörner, PD Dr. med. Dr. sc. nat.
SPZ
Outcome results
None listed