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ONWARD Empower BP pivotal study of the ARC-IM system (NCT07147296)
Lab or organization
ONWARD Empower BP pivotal study (NCT07147296)
The ongoing pivotal study of ONWARD’s ARC-IM implantable spinal stimulation system for symptomatic blood pressure instability in chronic spinal cord injury. Registry facts are from ClinicalTrials.gov (verified October 29, 2026). No results exist yet for this trial; the feasibility-stage evidence behind it is peer reviewed.
Study facts
| Field | Value and source scope |
|---|---|
| Registry | NCT07147296; interventional, randomized, crossover; triple masking (participant, investigator, outcomes assessor) [1] |
| Official title | ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury [1] |
| Sponsor | ONWARD Medical, Inc. [1] |
| Design | Pivotal, multicenter, prospective; 3-month double-blinded phase followed by a 21-month open-label phase [1] |
| Status | Recruiting [1] |
| Dates | Actual start October 17, 2025; primary completion estimated November 2026; study completion estimated March 2029 [1] |
| Enrollment | 60 (estimated) [1] |
| Population | Chronic spinal cord injury (more than 1 year) with symptomatic blood pressure instability [1] |
| Sites | 13 centers, including Craig Hospital, Shepherd Center/Emory, University of Miami, Mayo Clinic, Spaulding Rehabilitation, Kennedy Krieger, Columbia/NYP, VA sites in Louisville and the Bronx, and ICORD Vancouver [1] |
| Primary outcomes | Proportion achieving a change in the hypotension domain of the ADFSCI short-form questionnaire (3 months post-implant); proportion achieving systolic BP elevation during a seated BP test (3 months); incidence of serious adverse device effects (6 months) [1] |
Evidence behind the trial
| Field | Value and source scope |
|---|---|
| Feasibility evidence | In 14 participants, biomimetic epidural electrical stimulation of the spinal cord immediately triggered robust pressor responses, durably reduced the severity of hypotensive complications, removed the need for conservative treatments, and improved quality of life and engagement in daily activities [2] |
| Targeting finding | Head-to-head comparison in the same participants showed stimulation must target the last three thoracic segments, not the lumbosacral segments, for safe and effective blood-pressure regulation [2] |
| Stated path | The authors describe these findings as establishing the path to a pivotal device trial, which Empower BP is [2] |