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

NCT ID: NCT07234903

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2032-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subacute SCI

Participants having sustained the injury less than 6 weeks prior to baseline (subacute).

Participants will be provided with the ARC-IM Therapy.

Group Type: EXPERIMENTAL

ARC-IM Therapy

Intervention Type: 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

Participants having sustained the injury more than 1 year prior to enrollment (chronic).

Participants will be provided with the ARC-IM Therapy.

Group Type: EXPERIMENTAL

ARC-IM Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Jocelyne Bloch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jocelyne Bloch, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

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

Role: PRINCIPAL_INVESTIGATOR

SPZ

Locations

Schweizer Paraplegiker-Zentrum (SPZ)

Nottwil, Canton of Lucerne, Switzerland

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Central Contacts

Jocelyne Bloch, Prof. Dr. MD

Role: CONTACT

jocelyne.bloch@chuv.ch

+41 79 556 29 51

Facility Contacts

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

Role: primary

bjoern.zoerner@paraplegie.ch

+41 41 939 58 50

Jocelyne Bloch, Prof. Dr. MD

Role: primary

jocelyne.bloch@chuv.ch

+41 79 556 29 51

References

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.

Reference Type: BACKGROUND

PMID: 24305828 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36352232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30382197 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35132264 (View on PubMed)

Other Identifiers

EIGER

Identifier Type: -

Identifier Source: org_study_id