A computational model for epidural electrical stimulation of spinal sensorimotor circuits.
Marco Capogrosso, Nikolaus Wenger, Stanisa Raspopovic...
https://pubmed.ncbi.nlm.nih.gov/24305828Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07234903
ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury
Led by Ecole Polytechnique Fédérale de Lausanne · Updated on 2026-04-21
12
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ARC-IM Therapy, which uses epidural electrical stimulation, to support and promote the recovery of walking and other ambulatory functions in people with subacute and chronic spinal cord injuries. The study includes adults aged 18 to 65 who have sustained a traumatic spinal cord injury either less than 6 weeks ago (subacute) or more than 1 year ago (chronic). The goal is to assess the safety and preliminary effectiveness of this device in improving mobility. All participants will receive the ARC-IM Therapy, which delivers electrical impulses to the lower spinal cord region to aid walking. The study groups are divided by injury timing: one group with injuries less than 6 weeks old and another with injuries more than 1 year old. This device treatment will be monitored continuously throughout the study. Participants will undergo assessments including neurological classification, walking tests (10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go), walking indexes, gait analysis, goal attainment, and balance scales at baseline and multiple intervals up to 42 weeks after surgery. Safety is closely monitored throughout the study, focusing on any serious or related adverse events from implantation until study end, which can last up to 6 years. Participants must attend all scheduled visits and comply with the study requirements.
CONDITIONS
Brief Title
ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years at enrollment
- ASIA Impairment Scale grade A, B, C, or D
- Spinal cord injury level at T10 or higher with intact region above conus as shown by MRI
- Injury sustained either less than 6 weeks ago (subacute group) or more than 1 year ago (chronic group)
- Traumatic spinal cord injury
- Stable medical, physical, and psychological condition
- Residual upper limb function to support weight bearing
- Ability to communicate in German, French, or English
- Willingness to comply with study conditions and attend all visits
- Signed informed consent prior to study procedures
- Use of effective contraception for women of childbearing potential
You will not qualify if you...
- Pregnant or breastfeeding
- Brain damage
- History of epilepsy
- Participation in another clinical study with drugs or devices within 30 days before or during this study
- Previous stem cell injection in spinal cord
- Conditions increasing risks of spinal cord injury surgery
- Need for ventilator support
- Contraindications to mobility such as unhealed fractures or nerve disorders
- Non-traumatic spinal cord injury causes (ischemic, tumoral, autoimmune, etc.)
- Anatomical limitations at implantation area like spinal stenosis or bone damage
- Use of intrathecal baclofen pump
- Active implanted devices
- Other conditions preventing participation such as kidney, liver, or heart problems
- Investigator, family members, employees, or dependent persons involved in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 42 weeks post-implantation
Participants receive the ARC-IM Therapy, which delivers electrical impulses to the lumbosacral region of the spinal cord to support ambulatory functions.
Visits at Baseline, 6 weeks, 16 weeks, and 42 weeks post-implantation
Follow-up
Duration - Up to 6 years
Participants are monitored for safety and recovery outcomes following ARC-IM Therapy.
Continuous monitoring throughout the study period
Trial Site Locations
Total: 2 locations
1
Schweizer Paraplegiker-Zentrum (SPZ)
Nottwil, Canton of Lucerne, Switzerland, 6207
Not Yet Recruiting
2
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Loading map...
Research Team
J
Jocelyne Bloch, Prof. Dr. MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
The neurons that restore walking after paralysis.
Claudia Kathe, Michael A Skinnider, Thomas H Hutson...
https://pubmed.ncbi.nlm.nih.gov/36352232Targeted neurotechnology restores walking in humans with spinal cord injury.
Fabien B Wagner, Jean-Baptiste Mignardot, Camille G Le Goff-Mignardot...
https://pubmed.ncbi.nlm.nih.gov/30382197Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis.
Andreas Rowald, Salif Komi, Robin Demesmaeker...
https://pubmed.ncbi.nlm.nih.gov/35132264