Spinal Cord InjuryEIGERNCT07234903
ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury
A study testing ARC-IM Therapy in people with Spinal Cord Injury and SCI, run by Ecole Polytechnique Fédérale de Lausanne at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, SCI, SCI - Spinal Cord Injury
- What is being tested?
- ARC-IM Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2026to Apr 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years old and no older than 65 years old at the time of enrollment.
- Must be graded A, B, C, or D in the ASIA Impairment Scale (AIS).
- 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.
- 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").
- Must be suffering from a SCI due to trauma.
- Must have a stable medical, physical and psychological condition as considered by the investigators and the delegated specialists.
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- Must have residual upper limb function to use the arms for weight bearing support (as determined by functional demonstration).
- Must be able to understand and interact with the study team in German, French or English.
- Must agree to comply in good faith with all conditions of the study and to attend all scheduled appointments.
- Must provide Informed Consent as documented by signature prior to any study-related procedures.
- Must have an acceptable or highly effective method of contraception for women of childbearing capacity.
Who cannot join
- Must not be pregnant nor breastfeeding.
- Must not have brain damage.
- Must not have a history of epilepsy
- Must not have participated in another clinical study using drugs or medical devices within the 30 days preceding and during the present study.
- Must not have previously been injected with stem cells in the spinal cord.
- Must not have any diseases and conditions that would increase the morbidity and mortality of SCI surgery.
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- Must not require ventilator support.
- Must not have any existing contraindication to mobility functions (e.g., unhealed bone fractures, central nervous system disorder, peripheral nerve disorder, etc.).
- Must not suffer from SCI from other etiology than trauma (ischemic, tumoral, autoimmune, etc.).
- 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).
- Must not require the use of an intrathecal baclofen pump.
- Must not have any active implanted devices.
- 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.).
- Must not be the investigator him/herself, his/her family members, employees or other dependent persons.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Jocelyne Bloch, Prof. Dr. MD, +41 79 556 29 51, jocelyne.bloch@chuv.ch
Jocelyne Bloch, Prof. Dr. MD
- Not yet recruiting
Schweizer Paraplegiker-Zentrum (SPZ)
Nottwil, Canton of Lucerne, 6207
Björn Zörner, PD Dr. med. Dr. sc. nat., +41 41 939 58 50, bjoern.zoerner@paraplegie.ch
Björn Zörner, PD Dr. med. Dr. sc. nat.
About this study
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.
- Conditions
- Spinal Cord Injury, SCI, SCI - Spinal Cord Injury, Subacute Spinal Cord Injury, Chronic Spinal Cord Injury, Spinal Cord Injury (SCI)
- Being tested
- ARC-IM Therapy
- Keywords
- SCI, Spinal Cord Injury, Epidural Electrical Stimulation, Spinal Cord Stimulation, ARC-IM Therapy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-IM TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subacute SCI | Experimental | Participants having sustained the injury less than 6 weeks prior to baseline (subacute).
Participants will be provided with the ARC-IM Therapy. Receives: Device: ARC-IM Therapy |
| Chronic SCI | Experimental | Participants having sustained the injury more than 1 year prior to enrollment (chronic).
Participants will be provided with the ARC-IM Therapy. Receives: Device: ARC-IM Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Continuously throughout the study (up to 6 years)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Baseline, and at 6 weeks, 16 weeks, 42 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study startApr 2026 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, two-arms, non-blinded, non-randomized, interventional
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois
- Investigators
- Jocelyne Bloch, Prof. Dr. MD, Principal investigator, CHUVBjörn Zörner, PD Dr. med. Dr. sc. nat., Principal investigator, SPZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234903
- Sponsor's protocol ID
- EIGER
- Acronym
- EIGER
- Status last verified
- Apr 2026
- First submitted
- 1 Sep 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24305828Kathe 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.
PubMed 36352232Wagner 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.
PubMed 30382197Rowald 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.
PubMed 35132264