Testing ARC-IM System Implantation with ARC-IM Therapy (Group 1) against a placebo for spinal cord injuries

Exclusion

• −Known allergic reaction to implanted materials
• −Subject has an autoimmune etiology of spinal cord dysfunction/injury.
• −Subject has diseases and conditions that would increase the morbidity and mortality of the surgical procedures required by the study.
• −Subject has a history of physiologic hypotension prior to SCI
• −Subject has a history of unexpected blood pressure instability related to medications
• −Inability to withhold antiplatelet/anticoagulation agents perioperatively.
• −History of myocardial infarction or cerebrovascular event within the past 6 months. or
• −History of chronic/recurrent severe cardiac arrythmias (e.g., ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block)
• −Evidence of clinically significant underlying cardiac conditions on Holter monitoring performed at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → including but not limited to arrhythmias (e.g., atrial fibrillation, ventricular tachycardia),
• −Evidence of ischemic changes or prolonged QT interval (QTc \> of 450 ms for males and 470 ms for females) identified on EKG during screening,
• −Subjects with a known diagnosis of heart failure, including but not limited to New York Heart Association (NYHA) Class I-IV, or with evidence of clinically significant left ventricular dysfunction (ejection fraction \< 40%) as determined by echocardiogram during screening or within the past 6 months,
• −Current renal/kidney, hepatic, or other concomitant disorders deemed severe by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → including those ones that could be linked to severe autonomic dysreflexia.
• −Requires continuous ventilator support.
• −Imaging (MRI, CT, X-ray) findings within the last 12 months that contraindicate lead placement
• −Requires continuous/frequent/any transcutaneous spinal cord stimulation treatment.
• −Has any active implanted medical device (e.g. baclofen pump, pacemaker).
• −Inability to receive a pre-operative MRI.
• −Presence of pressure sore at time of screening or baselineBaselineYour starting measurements, taken before treatment begins.Read more → graded stage 3 or 4 .
• −Subject is enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → or intends to participate in another clinical drug and/or device study or registry that may interfere with the results of this study, as determined by ONWARD Medical personnel.
• −Presence of other anatomic or comorbid conditions, or other medical, social, or psychologic conditions such as severe uncontrolled neuropathic pain, depression, history of alcohol or substance abuse, history of schizophrenia or psychotic illness, severe personality disorder or other significant psychiatric or cognitive disorders that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → requirements of the clinical investigation.
• −Female subject who is pregnant, breastfeeding or planning to become pregnant or breastfeed. Women of child-bearing potential must have a negative pregnancy test completed at baseline visit per siteTrial siteA hospital or clinic where a study is actually run.Read more → standard test.