NL-OMON53314
Recruiting
Not Applicable
ARC Therapy to restore hemodynamic stability and trunk control in people with spinal cord injury - HemON
ONWARD Medical0 sites8 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- epidural lesion
- Sponsor
- ONWARD Medical
- Enrollment
- 8
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 18 years of age or older
- •\- Must provide and sign the Informed Consent prior to any study\-related
- •\- 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
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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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