Spinal Cord InjuriesEmpower BPNCT07147296
ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
A study testing ARC-IM System Implantation, ARC-IM Therapy (Group 1) and ARC-IM Therapy (Group 2) in people with Spinal Cord Injuries and Blood Pressure Disorders, run by ONWARD Medical, Inc. at 13 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Blood Pressure Disorders
- What is being tested?
- ARC-IM System Implantation, ARC-IM Therapy (Group 1) and ARC-IM Therapy (Group 2)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 17 Oct 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or above, and no older than 75 years at the time of enrollment.
- Clinical evidence of Orthostatic Hypotension (blood pressure drop of 20mmHg systolic or 10mmHg diastolic) measured during Head Up Tilt Table assessment (HUTT, within 10 minutes) with current standard of care if any. 2 out of 3 tests must meet OH criteria.
- Clinical evidence of sustained hypotension (average systolic Blood pressure ≤ 110 mmHg) when measured each minute for 10 minutes while seated and in the absence of supportive compressive garments and medication.
- Evidence of symptomatic hypotension as determined by a non-zero OHSA total score
- A Spinal cord injury at the neurologic level between C2 and T6 inclusive.
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A, B, C, or D.
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- Traumatic (non-progressive) chronic spinal cord injury with minimum 12 months post-injury prior to study entry.
- Average A-P diameter of the sponal canal ≥ 13 mm, measured on MRI at the disc space at level(s) planned for implantation
- Stable medical, physical, and psychological condition as considered by the investigators.
- Stable dose of blood pressure medication for 30-days prior to enrollment into the study . Stability will be defined as no changes to medication regimens based on treating physician instructions.
- Subjects who are on long-term antihypertensive treatment must discontinue these medications no less than 30 days prior to enrollment in the study. This requirement does not apply to antihypertensive agents administered for the acute management of autonomic dysreflexia (AD)
- If the subject requires daily continuous support from a personal caregiver, the presence of a caregiver during the study visits is mandatory.
- Willing and able to provide informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Willing and able to comply with the instructions for use, operate the study devices, and comply with this clinical investigation plan
Who cannot join
- 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
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- 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 screening 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 Investigator 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
- Known allergic reaction to implanted materials
- 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.
- 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 site standard test.
- Presence of pressure sore at time of screening or baseline graded stage 3 or 4 .
- Subject is enrolled 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-up requirements of the clinical investigation.
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
United States12 sites, 12 recruiting
- Recruiting
Shepherd Center / Emory University
Atlanta, Georgia, 30309
Casey Kandilakis, PT, DPT, 404-350-3066, casey.kandilakis@shepherd.org
- Recruiting
Kennedy krieger Institute
Baltimore, Maryland, 21205
Shannon Lorden, (410) 710-7930, LordenS@kennedykrieger.org
Cristina Sadowsky
- Recruiting
Spaulding Rehabilitation
Cambridge, Massachusetts, 02138
Noah Piazza, 617-952-6953, npiazza2@mgb.org
- Recruiting
Craig Hospital
Englewood, Colorado, 80113
Clare Morey, 303-789-8621, cmorey@craighospital.org
- Recruiting
University of Arkansas for medical Sciences
Little Rock, Arkansas, 72205
Urvashi Kalola, 501-398-8622, TRICoordinators@uams.edu
Anja Rassmann
- Recruiting
UofL Health - Frazier Rehabilitation Institute
Louisville, Kentucky, 40202
Andrea Willhite, 502-581-8675, andrea.willhite@louisville.edu
- Recruiting
VA Louisville
Louisville, Kentucky, 40245
Anne Marie Webb, (502) 287-5238, anne.webb@va.gov
Dylan Pfost, (502) 287-5238, dylan.pfost@va.gov
- Recruiting
University of Miami
Miami, Florida, 33136
Nilanjana Datta, 305-243-6798, nxd693@med.miami.edu
lesliemorse@miami.edu
- Recruiting
Columbia University Irving Medical Center/ New York-Presbyterian Hospital
New York, New York, 10032
Jason Carmel, 212-305-2700, jbc28@cumc.columbia.edu
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Michael McGehee, 971-509-4932, nsgclinicalresearch@ohsu.edu
- Recruiting
Mayo clinic
Rochester, Minnesota, 55905
Candee Mills, 507-284-2511, mills.candee@mayo.edu
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Dylan Arnero, (718) 584-9000, Dylan.Arnero@va.gov
Canada1 site, 1 recruiting
- Recruiting
ICORD
Vancouver, British Columbia, V5Z 1N1
Leilani Reichl, 604 875 4111 ext. 62853, Leilani.Reichl@vch.ca
About this study
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.
- Conditions
- Spinal Cord Injuries, Blood Pressure Disorders
- Being tested
- ARC-IM System Implantation, ARC-IM Therapy (Group 1), ARC-IM Therapy (Group 2)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-IM System ImplantationProcedure or surgery
Implantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator
ARC-IM Therapy (Group 1)Device
The ARC-IM System is programmed since day 0 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury
ARC-IM Therapy (Group 2)Device
The ARC-IM System is programmed at month 3 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | ARC-IM System with active stimulation since day 0 Receives: Procedure: ARC-IM System Implantation; Device: ARC-IM Therapy (Group 1) |
| Group 2 | Sham comparator | ARC-IM System without active stimulation before the open-label phase of the study Receives: Procedure: ARC-IM System Implantation; Device: ARC-IM Therapy (Group 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire
Proportion of subjects achieving a reduction of ≥ 4 points in the hypotension domain of the ADFSCI short-form questionnaire compared to baseline
Measured: 3-months post-implant
Proportion of subjects achieving elevation in SBP during seated BP test
Proportion of subjects achieving an elevation of ≥ 10 mmHg in systolic blood pressure during the seated BP test with stimulation ON compared to stimulation OFF
Measured: 3-months post-implant
Incidence of serious adverse device effects
Description of all Serious Adverse Device Effects from ARC-IM System implant until Month 6
Measured: 6-months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start17 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, controlled study consisting of a 3-month double-blinded phase followed by a 21-month open-label phase
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ONWARD Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147296
- Sponsor's protocol ID
- ONWD-IM-001
- Acronym
- Empower BP
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07147296
- Acronym / sponsor ID
- Empower BP / ONWD-IM-001
- Conditions
- Spinal Cord Injuries, Blood Pressure Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ONWARD Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled study consisting of a 3-month double-blinded phase followed by a 21-month open-label phase
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: ARC-IM System Implantation, Device: ARC-IM Therapy (Group 1)ARC-IM System with active stimulation since day 0 |
| Group 2 | Sham comparator | Procedure: ARC-IM System Implantation, Device: ARC-IM Therapy (Group 2)ARC-IM System without active stimulation before the open-label phase of the study |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Aged 18 years or above, and no older than 75 years at the time of enrollment.
- Clinical evidence of Orthostatic Hypotension (blood pressure drop of 20mmHg systolic or 10mmHg diastolic) measured during Head Up Tilt Table assessment (HUTT, within 10 minutes) with current standard of care if any. 2 out of 3 tests must meet OH criteria.
- Clinical evidence of sustained hypotension (average systolic Blood pressure ≤ 110 mmHg) when measured each minute for 10 minutes while seated and in the absence of supportive compressive garments and medication.
- Evidence of symptomatic hypotension as determined by a non-zero OHSA total score
- A Spinal cord injury at the neurologic level between C2 and T6 inclusive.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC-IM System ImplantationImplantation of the ARC-IM Thoracic Lead in the epidural space and ARC-IM Neurostimulator | Procedure or surgery | Group 1, Group 2 |
| ARC-IM Therapy (Group 1)The ARC-IM System is programmed since day 0 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury | Device | Group 1 |
| ARC-IM Therapy (Group 2)The ARC-IM System is programmed at month 3 to deliver active electrical spinal cord stimulation at the low thoracic level for the management of symptomatic blood pressure instability in people with chronic spinal cord injury | Device | Group 2 |
Primary outcome
Proportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire
Time frame: 3-months post-implant
Proportion of subjects achieving a reduction of ≥ 4 points in the hypotension domain of the ADFSCI short-form questionnaire compared to baseline
Proportion of subjects achieving elevation in SBP during seated BP test
Time frame: 3-months post-implant
Proportion of subjects achieving an elevation of ≥ 10 mmHg in systolic blood pressure during the seated BP test with stimulation ON compared to stimulation OFF
Incidence of serious adverse device effects
Time frame: 6-months post-implant
Description of all Serious Adverse Device Effects from ARC-IM System implant until Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of Arkansas for medical Sciences
Little Rock, United States
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARC-IM System Implantation, ARC-IM Therapy (Group 1) and ARC-IM Therapy (Group 2) in people with Spinal Cord Injuries and Blood Pressure Disorders, run by ONWARD Medical, Inc. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving a change in the hypotension domain of the ADFSCI short-form questionnaire (time frame: 3-months post-implant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.