Empower BP
A clinical study evaluating the safety and effectiveness of the investigational ARCIM System* in managing symptomatic blood pressure instability in people with chronic spinal cord injury (SCI).
Discover
the Study
Blood pressure instability
When blood pressure fluctuates between inappropriately low or high values because of disruptions to the autonomic nervous system following SCI.
The Empower BP global pivotal study is a randomized, controlled, double-blinded study enrolling participants in leading centers across the US, Canada, and Europe.
Its purpose is to evaluate the safety and effectiveness of our investigational implantable ARCIM System, which is designed to address in individuals with chronic SCI (>1 year after injury)
Following an SCI, blood pressure (BP) can fluctuate between inappropriately low and high values due to disruptions in the autonomic nervous system.
Empower BP primarily investigates the ARCIM System’s impact on symptomatic orthostatic hypotension (OH), which is low BP caused by posture or changes in posture, for example transitioning from a reclined to upright position or staying in an upright position like sitting.
The study will also assess the potential effects of the therapy on improving autonomic dysreflexia (AD), a sudden and often dangerous rise in BP in response to a stimulus below the level of a spinal cord injury. Autonomic dysreflexia is commonly triggered by sensations (such as a full bladder or pain) that are no longer felt after a spinal cord injury.
Why now?
Symptomatic blood pressure instability is an underappreciated and unmet need after SCI, with symptoms that are often severe and debilitating.
78% of survey responders with tetraplegia are diagnosed with OH.**
Of those diagnosed, only 28% are treated.
Of those treated, 91% still experience symptoms.1
These symptoms include dizziness, lightheadedness, blurred vision, and fatigue.1
82% of survey responders with tetraplegia are diagnosed with AD.**
Of those diagnosed, only 30% are treated.
Of those treated, 98% still experience symptoms.2
These symptoms include headaches and heart palpitations, goosebumps and sweating, as well as anxiety.2
78% of survey responders with tetraplegia are diagnosed with OH.**
Of those diagnosed, only 28% are treated.
Of those treated, 91% still experience symptoms.1
These symptoms include dizziness, lightheadedness, blurred vision, and fatigue.1
82% of survey responders with tetraplegia are diagnosed with AD.**
Of those diagnosed, only 30% are treated.
Of those treated, 98% still experience symptoms.2
These symptoms include headaches and heart palpitations, goosebumps and sweating, as well as anxiety.2
Many people adjust their daily routines around potential triggers of BP instability, affecting quality of life. Over time, persistent low blood pressure can threaten neurological recovery and negatively impact cardiovascular health.1-3
**Based on results from the Spinal Cord Injury Community Survey (SCICS), which includes self-reported information on symptoms of OH and AD from 1,479 individuals living with chronic SCI.4,5
The ARCIM System
Hemodynamic Hotspot
A region over the last three segments of the lower thoracic spine containing a high density of neurons that regulate blood pressure. This area is the optimal site for precise stimulation to treat blood pressure instability following an SCI.
The investigational ARCIM System uses targeted, programmed stimulation of the spinal cord to address symptomatic blood pressure instability in individuals with SCI.
The System consists of a purpose-designed neurostimulator connected to a purpose-designed lead that targets the - a region in the thoracic spinal cord containing a high density of neurons that regulate blood pressure.
By precisely stimulating this area, ARCIM aims to reduce symptoms associated with blood pressure instability after SCI.1
Empower BP is Looking
for Participants
Here are the active centers, with more to be added.
FAQs
While ARCIM remains an investigational device and is only available as part of a clinical study, some preliminary benefits of participating in this research may include:
- Stable blood pressure
- Increased tolerance to position transfer
- Improved mental awareness
- Increased physical activity
- Greater engagement in rehabilitation and activities of daily living (ADLs)
- Improved quality of life
Every research study involves risks and discomforts that you should carefully consider. The main ones you may experience include:
Risks and side effects associated with the surgery:
- Risks associated with general anesthesia, such as bladder system infection, pneumonia, stroke, low level of oxygen in the blood, deep vein thrombosis, post-operative confusion and in very rare cases, death
- Risks associated with the surgical implant are similar to surgeries for chronic pain management
Risks and side effects associated with the implanted device:
- Failure or malfunction of any part of the devices
- Implanted devices may move from original implanted location
- There may be side effects which are unknown at this time
Please consult your study team or healthcare professional to understand the complete list of potential risk and discomforts.
To be eligible to participate in this study, you must:
- Be >1 year post-injury
- Be aged 18–75
- Have a traumatic, chronic spinal cord injury between levels C2–T6 (inclusive)
- Have been diagnosed with sustained hypotension (Systolic Blood pressure ≤ 110 mmHg)
- Have no history of hypotension prior to your injury
- Have an ASIA classification of A, B, C, or D
Conditions that would exclude you from participating include:
- History of heart attack, severe heart rhythm disorder, or stroke in the past six months
- Kidney or liver disease
- Being on a ventilator
- Having an active implanted medical device (e.g., baclofen pump or pacemaker)
- Being pregnant or breastfeeding
- Being unable to receive a spinal MRI
Please consult your study team or healthcare professional to understand the complete list of potential inclusion and exclusion criteria.
We expect your participation in this research study to last approximately 24–28 months, from the date you sign the informed consent through the final follow-up visit.
First, you will meet with a study specialist at a participating center to determine if the study is appropriate for you.
If you are considered a suitable candidate, and this is confirmed through screening and baseline assessments at the clinic, you will then undergo surgery to receive the implanted ARCIM System.
Following the procedure, you will have a series of follow-up visits over the course of 24 months to assess how the therapy works for you. These visits include:
- Programming visits to ensure the therapy is optimally tailored to your daily life,
- In-clinic visits to complete questionnaires and undergo clinical assessments, and
- Remote visits to respond to questionnaires via email and over the phone.
In total, you can expect to spend approximately 15 days attending in-person visits throughout the 2-year study.
You will be fully supported by your healthcare professional throughout the study. They will be available to answer your questions, address any concerns, and guide you through each step of the process.
Yes, your participation in the study is entirely voluntary and remains your decision at all times.
The protocol received IRB approval on August 26, 2025.
For more detailed information, go to www.clinicaltrials.gov. NCT:07147296
*Caution: Investigational device. The safety and effectiveness of this therapy are currently being evaluated in clinical studies and are under review by the U.S. Food and Drug Administration (FDA). Limited by United States law to investigational use.
- Phillips, A.A., et al. “An implantable system to restore hemodynamic stability after spinal cord injury.” Nature Medicine. 2025.
- Soriano, J.E., et al. “A neuronal architecture underlying autonomic dysreflexia.” Nature. 2025.
- Carlozzi NE, et al. “Impact of blood pressure dysregulation on health-related quality of life in persons with spinal cord injury: development of a conceptual model.” Arch Phys Med Rehabil. 2013.
- Noreau L, et al. “Development and assessment of a community follow-up questionnaire for the Rick Hansen spinal cord injury registry.” Arch Phys Med Rehabil. 2013.
- Noreau L, et al. “Spinal cord injury community survey: a national, comprehensive study to portray the lives of canadians with spinal cord injury.” Top Spinal Cord Inj Rehabil. 2014.