Baltimore, MDNCT03161067Now EnrollingIRB Ready

Tetraplegia Clinical Trial in Baltimore, MD

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

Sponsored by Johns Hopkins University

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Expert Care in Baltimore

Access tetraplegia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related tetraplegia treatment provided free

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Check if you qualify for this tetraplegia clinical trial in Baltimore, MD

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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 Tetraplegia Study in Baltimore

The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The goals of this early feasibility study consist of safety and efficacy evaluations of this device.

Sponsor: Johns Hopkins University

Who Can Participate

Inclusion Criteria

Participants must meet all inclusion criteria, verified by medical evaluation, psychological evaluation, and review of medical history. Inclusion criteria include:
Participants with C4-C6 tetraplegia from any etiology except neurodegenerative disease (e.g. amyotrophic lateral sclerosis) or active cancer.
Complete or incomplete spinal cord injury classified by the American Spinal Injury Association (ASIA) as A or B or C if fewer than three muscle groups in the leg and foot (as identified in the ASIA Impairment Scale) can be contracted
Injury more than one year prior to enrollment
Participant has a life expectancy of greater than 5 years
Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
Willingness and ability to provide informed consent
Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study
Ability and willingness to travel to up to fifty miles to study location up to three days per week for the duration of the study
Ability to understand and comply with study session instructions
Pain well controlled without narcotic medications
No other neurological, orthopedic conditions beyond the spinal cord injury
Participant consents to the study and still wishes to participate at the time of the study

Exclusion Criteria

All interested participants will be reviewed for the presence of exclusion criteria by medical evaluation, review of medical history, self (or assistant) report and evaluation by a psychologist. Presence of any of the following criteria will exclude participants from eligibility to participate. In addition, the medical team has the right to withdraw the participant at any time if any of the exclusion criteria emerge and participants can withdraw at any time for any reason. Withdrawal details are outlined below exclusion criteria. Exclusion criteria include:
Neurological conditions: Impaired receptive and/or expressive verbal communication skills
Presence of memory impairment on the Rey Auditory Verbal Learning Test
Intellectual impairment: score of 26 or less on the Mini-Mental State Examination or history of Intelligence Quotient \< 80
Chronic psychiatric illness, including psychosis and treatment-resistant major depression, as indicated by a diagnosis of Axis I or Axis II on the Symptom Checklist-90-Revised Test
Ventilator dependent
Implanted devices such as: pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, cochlear implants or any other implantable device incompatible with MRI.
History of drug or alcohol dependence in past 24 months
Cerebral lesions affecting frontal and parietal lobes
Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)
Other chronic, unstable medical conditions that could make control unsuitable (such as tremor or spasticity)
Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)
Prior cranioplasty
Inability to undergo MRI or anticipated need for an MRI during the study period
Participants with active infections or unexplained fever
Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, or renal impairments making the surgical procedure unsafe
Pregnancy (confirmation through blood test)
Nursing an infant, planning to become pregnant, or not using adequate birth control
Corrected vision no worse than 20/30
HIV or AIDS infection
Existing scalp lesions or skin breakdown
Chronic oral or intravenous use of steroids or immunosuppressive therapy
Active cancer within the past year or requires chemotherapy
Uncontrolled autonomic dysreflexia within the past 3 months
An implanted ventricular shunt
Suicidal ideation within the past 12 months
Medications that affect neuroplasticity: neuroleptics, Benzodiazepines (BDZ), Tricyclic Antidepressants (TCA).

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 (NCT03161067) 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.

Tetraplegia Treatment Options in Baltimore, MD

If you're searching for tetraplegia treatment options in Baltimore, MD, this clinical trial (NCT03161067) 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 tetraplegia 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.

Looking for more options? Browse all tetraplegia clinical trials near you to find additional studies recruiting in your area.

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