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Tests treatment safety and results for Spinal Cord Injuries
Official title 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 (BoxSwitch)
ClinicalTrials.gov ID: NCT05942339
What this study is testing
- What it's testing
- The purpose of this pre-market clinical study is to assess the preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System at supporting mobility in participants who have previously received a spinal array and an implantable pulse generator (IPG) either through the STIMO protocol (NCT02936453) or similar studies conducted abroad. They will be proposed to exchange their currently implanted system with components of the newly developed ARC-IM Lumbar system.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings.
- Age 18-65
- SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \& D
- SCI ≥ 12months
- SCI lesion level T10 and above with preservation of conus function
You likely can't join if
- Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- History of myocardial infarction or cerebrovascular event within the past 6 months
- Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical...
- Any active implanted cardiac device such as pacemaker or defibrillator
- Any indication that would require diathermy
- Any indication that would require MRI
See the full eligibility criteria
- Implanted with a spinal array (Specify 5-6-5 or Go2 Lead) for lower limb mobility, as confirmed by imaging, videos, or neurophysiology recordings.
- Age 18-65
- SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C \& D
- SCI ≥ 12months
- SCI lesion level T10 and above with preservation of conus function
- SCI due to trauma
- Stable medical, physical and psychological condition as considered by the investigators
- Able to understand and interact with the study team in French or English
- Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments
- Must provide and sign the Informed Consent prior to any study-related procedures
- Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery
- History of myocardial infarction or cerebrovascular event within the past 6 months
- Limitation of walking function based on accompanying (CNS) disorders (systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
- Any active implanted cardiac device such as pacemaker or defibrillator
- Any indication that would require diathermy
- Any indication that would require MRI
- Any anatomical limitations in the implantation area as judged by the investigators
- Other conditions that would make the subject unable to participate in testing in the judgement of the investigators
- Clinically significant mental illness in the judgement of the investigators
- Presence of indwelling baclofen or insulin pump
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia of the participant
- Enrolment of the investigator, his/her family members, employees, and other dependent persons
- Women who are pregnant (pregnancy test obligatory for women of childbearing potential) or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.