Assessing a new therapy to improve mobility in people with chronic spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.