BridgeMD
New treatment option for Spinal Cord Injuries
Official title ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
ClinicalTrials.gov ID: NCT07147296
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Clinical evidence of sustained hypotension (average systolic Blood pressure ≤ 110 mmHg) when measured each minute for 10 minutes while seated and in...
- 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.
You likely can't join if
- 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
See the full eligibility criteria
Who can 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...
- 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.
- 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.
- people 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...
- 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
What rules you out
- 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 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,
- people 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 \<...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Englewood, Colorado, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Cambridge, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Englewood, Colorado, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.