epidural lesion Spinal cord injury Damage of the spinal cord
Conditions
Interventions
Consent and eligibility
• Patients fulfilling eligibility criteria and willing to provide signed
informed consent are enrolled.
Baseline assessments (up to 8 weeks)
• A comprehensive assessment of d
Sponsors
ONWARD Medical
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria: - Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery - 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the occurrence of serious adverse events and adverse events that are deemed related or possibly related to the study procedure or to the ARC-IM Thoracic System, from implantation up to the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes with clinical impact: • Preliminary efficacy of ARC Therapy at supporting management of hemodynamic instability will be assessed via orthostatic head-up tilt tests, via continuous blood pressure monitoring using a wearable device, via a steady BP measurement, a seated BP test, and via the Mapping of Rehab Training (MART) forms filled by therapists during rehabilitation sessions • Effect of ARC Therapy on trunk control will be assessed with the Trunk Control Test (TCT), trunk stability measurements, wheelchair performance test, the Function In Sitting Test (FIST-SCI) test and CT scans. • Effect of ARC Therapy on spasticity will be evaluated with spasticity questionnaires filled by the participants and via the Modified Ashworth Scale (MAS) • Effect of ARC Therapy on daily life performance will be assessed with the Spinal Cord Independence Measure (SCIM III), with the Canadian Occupational Performance Measure (COPM) and with a daily life activities monitoring assessment Secondary outcomes with technical impact: • Evaluation of the independent use of ARC-IM Thoracic System, will be assessed with a stimulation usage log and weekly questionnaires, filled by the participants • Evaluation of the robustness of ARC-IM Thoracic System will be assessed based on the occurrence of Device Deficiencies, and by analysing the automatic logs recorded by the devices • Evaluation of the usability and clinical procedures of the ARC-IM Thoracic System by the different users will be assessed with a surgical checklist and different questionnaires to be filled about the system | — |
Countries
Netherlands
Contacts
Public ContactLD Duguet
ONWARD Medical
Outcome results
None listed