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

NCT07234903 | Recruiting DMC

• 1 other identifier: EIGER
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

SCI; Spinal Cord Injury; Epidural Electrical Stimulation; Spinal Cord Stimulation; ARC-IM Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 10-Meter Walk Test (10MWT)

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

• 6-Minute Walk Test (6MWT)

  At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

• Timed Up and Go (TUG)

  At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

• Walking Index for Spinal Cord Injury version II (WISCI II)

  At Baseline, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

Other Outcomes (15)

• 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

  At 6 weeks, 16 weeks, and 42 weeks post-surgery

• EES Evoked Muscle Response

  Every 2 days during the mapping phase, and at 6 weeks, 16 weeks, and 42 weeks post-surgery

Study Arms (2)

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.

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.

Device: ARC-IM Therapy

Interventions

ARC-IM Therapy DEVICE

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.

Chronic SCI; Subacute SCI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead

Study Sites (2)

Schweizer Paraplegiker-Zentrum (SPZ)

Nottwil, Canton of Lucerne, 6207, Switzerland

NOT YET RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (4)

• 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.

  PMID: 24305828 BACKGROUND

• 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.

  PMID: 36352232 BACKGROUND

• 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.

  PMID: 30382197 BACKGROUND

• 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.

  PMID: 35132264 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jocelyne Bloch, Prof. Dr. MD

  CHUV

  PRINCIPAL INVESTIGATOR

• Björn Zörner, PD Dr. med. Dr. sc. nat.

  SPZ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyne Bloch, Prof. Dr. MD

CONTACT

+41 79 556 29 51; jocelyne.bloch@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicentric, two-arms, non-blinded, non-randomized, interventional

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: November 19, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CH (2)