Assessing a new therapy to improve mobility in people with chronic spinal cord injury
Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury
This study is testing a new therapy to see if it can help people with chronic spinal cord injuries move better and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ecole Polytechnique Fédérale de Lausanne Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT05942339 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System for enhancing mobility in individuals with chronic spinal cord injuries. Participants who have previously completed the STIMO study will have their existing implanted systems replaced with the new ARC-IM components. The study aims to improve lower-limb motor activities and assess the therapy's impact on muscle tone, bladder, bowel, sexual functions, and overall quality of life. The intervention includes several phases, from pre-screening to follow-up assessments over 36 months.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-65 who have completed the STIMO study and have chronic spinal cord injuries graded as AIS A, B, C, or D.
Not a fit: Patients with conditions that increase the risks associated with spinal cord injury surgery or those who have not participated in the STIMO study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance mobility and quality of life for individuals with chronic spinal cord injuries.
How similar studies have performed: Previous studies using electrical epidural stimulation have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings. 2. Age 18-65 3. SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \& D 4. SCI ≥ 12months 5. SCI lesion level T10 and above with preservation of conus function 6. SCI due to trauma 7. Stable medical, physical and psychological condition as considered by the investigators 8. Able to understand and interact with the study team in French or English 9. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments 10. Must provide and sign the Informed Consent prior to any study-related procedures Exclusion Criteria: 1. Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery 2. History of myocardial infarction or cerebrovascular event within the past 6 months 3. Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders) 4. Any active implanted cardiac device such as pacemaker or defibrillator 5. Any indication that would require diathermy 6. Any indication that would require MRI 7. Any anatomical limitations in the implantation area as judged by the investigators 8. Other conditions that would make the subject unable to participate in testing in the judgement of the investigators 9. Clinically significant mental illness in the judgement of the investigators 10. Presence of indwelling baclofen or insulin pump 11. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) 12. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant 13. Enrolment of the investigator, his/her family members, employees, and other dependent persons 14. Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding
Where this trial is running
Lausanne, Canton of Vaud
- Chuv — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jocelyne Bloch, MD — Chuv
- Study coordinator: Grégoire Courtine, Prof
- Email: gregoire.courtine@epfl.ch
- Phone: +41 21 69 30762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.