ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury

ClinicalTrials.gov ID: NCT07147296

Public ClinicalTrials.gov record NCT07147296. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 8:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.

Study identification

NCT ID: NCT07147296
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: ONWARD Medical, Inc.; Industry
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

Procedure · Device

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 16, 2025
Primary completion: Oct 31, 2026
Completion: Feb 28, 2029
Last update posted: Jun 15, 2026

2025 – 2029

United States locations

U.S. sites: 12
U.S. states: 10
U.S. cities: 11

Facility	City	State	ZIP	Site status
University of Arkansas for medical Sciences	Little Rock	Arkansas	72205	Recruiting
Craig Hospital	Englewood	Colorado	80113	Recruiting
University of Miami	Miami	Florida	33136	Recruiting
Shepherd Center / Emory University	Atlanta	Georgia	30309	Recruiting
UofL Health - Frazier Rehabilitation Institute	Louisville	Kentucky	40202	Recruiting
VA Louisville	Louisville	Kentucky	40245	Recruiting
Kennedy krieger Institute	Baltimore	Maryland	21205	Recruiting
Spaulding Rehabilitation	Cambridge	Massachusetts	02138	Recruiting
Mayo clinic	Rochester	Minnesota	55905	Recruiting
Columbia University Irving Medical Center/ New York-Presbyterian Hospital	New York	New York	10032	Recruiting
James J. Peters VA Medical Center	The Bronx	New York	10468	Recruiting
Oregon Health & Science University	Portland	Oregon	97239	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07147296, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 15, 2026 · Synced Sep 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07147296 live on ClinicalTrials.gov.

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