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

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 Overview

• Status: Recruiting
• Conditions: Chronic Spinal Cord Injury; Spinal Cord Injury (SCI); Spinal Cord Injury; SCI - Spinal Cord Injury; SCI; Subacute Spinal Cord Injury
• Intervention / Treatment: Device: ARC-IM Therapy

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jocelyne Bloch, Prof. Dr. MD; Phone Number: +41 79 556 29 51; Email: jocelyne.bloch@chuv.ch

Study Locations

• Switzerland
  • Canton of Lucerne
    • Nottwil, Canton of Lucerne, Switzerland, 6207
      • Not yet recruiting
      • Schweizer Paraplegiker-Zentrum (SPZ)
      • Contact: Björn Zörner, PD Dr. med. Dr. sc. nat.; Phone Number: +41 41 939 58 50; Email: bjoern.zoerner@paraplegie.ch
      • Principal Investigator: Björn Zörner, PD Dr. med. Dr. sc. nat.
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Contact: Jocelyne Bloch, Prof. Dr. MD; Phone Number: +41 79 556 29 51; Email: jocelyne.bloch@chuv.ch
      • Principal Investigator: Jocelyne Bloch, Prof. Dr. MD
      • Sub-Investigator: Grégoire Courtine, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subacute SCI; Participants having sustained the injury less than 6 weeks prior to baseline (subacute). Participants will be provided with the ARC-IM Therapy.	Device: ARC-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.
Experimental: Chronic SCI; Participants having sustained the injury more than 1 year prior to enrollment (chronic). Participants will be provided with the ARC-IM Therapy.	Device: ARC-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Continuously throughout the study (up to 6 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Timed Up and Go (TUG)	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.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Walking Index for Spinal Cord Injury version II (WISCI II)	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.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)	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.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Gait Analysis	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.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Goal Attainment Scale (GAS)	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.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Berg Balance Scale (BBS)	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.	At Baseline, and at 6 weeks, 16 weeks, 42 weeks post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARC-IM stimulation usage log	Independent use of the ARC-IM Lumbar System by study participants will be evaluated through analysis of the ARC-IM stimulation usage log.	At 6 weeks, 16 weeks, 42 weeks post-surgery, and at the end of the study
Integration of ARC-IM Therapy within the standard-of-care	Integration of ARC-IM Therapy within the standard-of-care for subacute SCI will be evaluated by quantifying its use within standard clinical mobility rehabilitation procedures. This will be achieved by extracting and comparing data of the Stimulation Usage Log and Participant's Calendar Log.	At 6 weeks, 16 weeks, and 42 weeks post-surgery
EES Evoked Muscle Response	Effect of ARC-IM Therapy on the modulation of the spinal cord will be evaluated through electrophysiological assessments that will quantify the muscle responses to EES and adaptation of these responses over time.	Every 2 days during the mapping phase, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Function In Sitting Test for Spinal Cord Injury (FIST-SCI)	Effect of ARC-IM Therapy on trunk stability will be evaluated using the FIST-SCI. The FIST-SCI assesses sitting balance. It evaluates sensory, motor, proactive, reactive, and steady state balance factors based on 14 items, each scored on an ordinal scale from 0 to 4, where 0 means complete assistance is needed to perform the task successfully, and 4 means can complete the task independently and successfully. The test will be conducted both with and without stimulation.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks after surgery
Modified Ashworth Scale (MAS)	Effect of ARC-IM Therapy on muscle tone will be evaluated using the MAS. The MAS assesses spasticity in a participant's upper and lower limb, by rating the resistance of a muscle to passive movement at a single joint on a 6-point nominal scale, where 0 means no increase in tone, and 5 means affected parts are rigid in flexion or extension. The clinical examination will be performed both with and without stimulation on different days at similar times. Antispastic medication and time points of test/medication intake will be documented.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Spinal Cord Assessment Tool for Spastic Reflexes (SCATS)	Effect of ARC-IM Therapy on muscle tone will be evaluated using the SCATS. The SCATS assesses 3 types of spastic motor behaviors in SCI patients - clonus, flexor spasms, and extensor spasms. The clinical examination will be performed both with and without stimulation. Antispastic medication and start time of the test will be documented for inter-test reliability.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Spinal Cord Injury - Quality of Life Short form (SCI-QoL SF)	Effect of ARC-IM Therapy on quality of life will be evaluated with the SCI-QoL SF. The SCI-QoL SF is a PROM for individuals with SCI. It is divided into 4 domains (emotional health, physical-medical health, social participation, physical functioning) with a selection of 22 subdomains. Each subdomain has several items. The participant rates each item with a number between 1 and 5 according to the extent to which the statement it contains applies to them. Each subdomain is scored separately. The higher the score, the higher the participant's perceived quality of life.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)	Effect of ARC-IM Therapy on quality of life for chronic SCI participants will be evaluated with the EQ-5D-5L questionnaire. The EQ-5D-5L is a PROM that describes the patient's health state for five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.	At Baseline, at 6 weeks, 16 weeks, and 42 weeks post-surgery, and yearly until the end of study
Patient Global Impression of Change (PGI-C)	Effect of ARC-IM Therapy on the subjective change of overall status will be evaluated with the PGI-C. The PGI-C is a single-item questionnaire to measure the change of clinical status, injury severity, or injury improvement, and evaluate the response of a condition to the given therapy. It is a 7-point scale where the participant rates his/her improvement or deterioration on a scale from "1 = very much improved" to "7 = very much worse".	At 6 weeks, 16 weeks, and 42 weeks post-surgery
Spinal Cord Independence Measure (SCIM) III	Effect of ARC-IM Therapy on functional independence in daily living will be evaluated with the SCIM III score. The SCIM III is a disability score that addresses functional ability in daily living in people with SCI. Three specific areas are assessed: self-care (0-20 points), respiration and sphincter management (0-40 points), and mobility (0-40 points). The form will be filled out as per stimulation use of the participant in his/her daily life activities for with or without stimulation condition. Total score ranges between 0 and 100 points, with higher scores reflecting greater independence.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
System Usability Scale (SUS)	The SUS is a standardized post-usability test questionnaire comprised of 10 Likert-scale questions used to evaluate the usability of the investigational system. To collect the SUS score, participants rate how strongly they agree or disagree with statements on a 1 (strongly disagree) to 5 (strongly agree) scale.	At 6 weeks, 16 weeks, and 42 weeks post-surgery
EMSCI Pain Assessment Form (EPAF)	Effect of ARC-IM Therapy on pain will be evaluated with the EPAF. The EPAF is used for classification of existing pain problems in people with SCI. The clinical assessment form consists of 12 items and follows the international guidelines and recommendations for the clinical documentation and assessment of pain in SCI. One overall form will be completed summarizing with and without stimulation condition.	At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery
Dual-Energy X-Ray Absorptiometry (DEXA)	Effect of ARC-IM Therapy on bone mineral density will be evaluated using DEXA. Participants will lie in a supine position during the scan, following standardized protocols.	At Baseline and at 42 weeks post-surgery
Quantitative Computed Tomography (QCT)-Scan	Effect of ARC-IM Therapy on muscle mass will be evaluated using QCT-Scan. The QCT-Scan is used to assess muscle mass by providing high-resolution cross-sectional images of the thigh and the trunk. It allows for precise measurement of muscle volume and composition. Participants will undergo the scan in a supine position, and standardized protocols will be used to ensure consistency across time points.	At Eligibility and at 42 weeks post-surgery
Additional User Feedback	The Additional User Feedback is a form designed to collect qualitative feedback from participants regarding their interaction with the ARCIM Lumbar System. It includes rating items to evaluate satisfaction (from "not satisfied at all" to "very satisfied") and open-ended questions addressing ease of use, satisfaction with system components such as battery life, charging time, connection stability, and overall comfort during use.	At 6 weeks, 16 weeks, and 42 weeks post-surgery

Collaborators and Investigators

• Sponsor: Ecole Polytechnique Fédérale de Lausanne
• Investigators: Principal Investigator: Jocelyne Bloch, Prof. Dr. MD, CHUV; Principal Investigator: Björn Zörner, PD Dr. med. Dr. sc. nat., SPZ

Publications and helpful links

General Publications

• Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.
• Capogrosso M, Wenger N, Raspopovic S, Musienko P, Beauparlant J, Bassi Luciani L, Courtine G, Micera S. A computational model for epidural electrical stimulation of spinal sensorimotor circuits. J Neurosci. 2013 Dec 4;33(49):19326-40. doi: 10.1523/JNEUROSCI.1688-13.2013.
• Kathe C, Skinnider MA, Hutson TH, Regazzi N, Gautier M, Demesmaeker R, Komi S, Ceto S, James ND, Cho N, Baud L, Galan K, Matson KJE, Rowald A, Kim K, Wang R, Minassian K, Prior JO, Asboth L, Barraud Q, Lacour SP, Levine AJ, Wagner F, Bloch J, Squair JW, Courtine G. The neurons that restore walking after paralysis. Nature. 2022 Nov;611(7936):540-547. doi: 10.1038/s41586-022-05385-7. Epub 2022 Nov 9.
• Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032

Study Registration Dates

• First Submitted: September 1, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Spinal Cord Stimulation; SCI; Epidural Electrical Stimulation; ARC-IM Therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: EIGER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No