Using ARC Therapy to Improve Blood Pressure and Movement Control in Spinal Cord Injury Patients
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
This study is testing if a new therapy that uses electrical stimulation can help people with spinal cord injuries improve their blood pressure and control their movements better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ONWARD Medical, Inc. Industry-sponsored |
| Locations | 1 site (Ubbergen) |
| Trial ID | NCT05941819 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the safety and preliminary effectiveness of the ARC-IM Therapy, which involves implanting the ARC-IM Thoracic System to deliver targeted epidural electrical stimulation. The therapy is designed to enhance hemodynamic management in individuals with sub-acute or chronic spinal cord injuries, specifically those experiencing orthostatic hypotension. Participants will be monitored for improvements in blood pressure stability and trunk control following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with traumatic spinal cord injuries at specific lesion levels and confirmed orthostatic hypotension.
Not a fit: Patients with conditions that complicate spinal cord injury surgery or those requiring regular MRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve blood pressure regulation and trunk control for patients with spinal cord injuries.
How similar studies have performed: While this approach is innovative, similar studies exploring electrical stimulation for spinal cord injury have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Must provide and sign the Informed Consent prior to any study-related procedures * Traumatic Spinal Cord Injury * Spinal cord injury lesion level between C3 and T6 (inclusive) * AIS- A, B, C or D * SCI ≥ 1month * Confirmed orthostatic hypotension * Stable medical, physical and psychological condition as considered by the investigators * Able to understand and interact with the study team in Dutch or English * Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments * In case participants need continuous support from a personal caregiver in daily life, then the presence of their caregiver during the visits to the study site is needed, including independent transport (not dependent on a cab) Exclusion Criteria: * Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery * Diseases and conditions that would require regular MRI * The inability to perform an MRI due to metal, magnetic or electrical device in the body (e.g. oral implant with magnet, mtal splinter, neurostimulator, artificial heart valve, clips, stents...) as assessed by the MRI form of Sint Maartenskliniek * The inability to withhold antiplatelet/anticoagulation agents perioperatively * History of myocardial infarction or cerebrovascular event within the past 6 months * 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 * Botulinum toxin non-vesical and vesical injections in the previous 3 months before the enrolment * Presence of significant pressure ulcers * Recurrent urinary tract infection refractory to antibiotics * Presence of indwelling baclofen (e.g. intrathecal baclofen pump) or insulin pump * Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding * Lack of safe contraception for women of childbearing capacity * Intention to become pregnant during the course of the study, * 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 * Participation in another study with investigational drug within the 30 days preceding and during the present study * Enrolment of the investigator, his/her family members, employees, and other dependent persons
Where this trial is running
Ubbergen
- Sint Maartenskliniek — Ubbergen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Ilse Van Nes, MD, PhD — Sint Maartenskliniek, department of rehabilitation
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.