Baltimore, MDNCT07147296Now EnrollingIRB Ready

Spinal Cord Injuries Clinical Trial in Baltimore, MD

Access cutting-edge spinal cord injuries treatment through this clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by ONWARD Medical, Inc.

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Expert Care in Baltimore

Access spinal cord injuries specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related spinal cord injuries treatment provided free

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Check if you qualify for this spinal cord injuries clinical trial in Baltimore, MD

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Spinal Cord Injuries Study in Baltimore

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.

Sponsor: ONWARD Medical, Inc.

Who Can Participate

Inclusion Criteria

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.
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

Exclusion Criteria

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,
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07147296) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Spinal Cord Injuries Treatment Options in Baltimore, MD

If you're searching for spinal cord injuries treatment options in Baltimore, MD, this clinical trial (NCT07147296) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced spinal cord injuries specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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Secure · Expert Care · Baltimore, MD