Is NCT01894802 recruiting in Chicago, IL?

Yes, NCT01894802 is currently recruiting participants at its Chicago, IL location. This tetraplegia clinical trial is actively enrolling qualified participants.

How do I join the tetraplegia clinical trial in Chicago?

To join this clinical trial in Chicago, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Chicago clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Tetraplegia Clinical Trial in Chicago, IL

Who Can Participate

Inclusion Criteria

Subjects must have limited or no ability to use one or both hands due to cervical spinal cord injury, brainstem stroke, brachial plexus injury, above-elbow amputation, or spinal stroke. Individuals with intact limbs must have less than grade 2 strength in finger flexor and abduction on the contralateral side to the implant and a t-score \<35 on the PROMIS Upper Extremity Short Form. The non-functional hand(s) may be involved passively in functional tasks; for example, pushing an object or passively grasping an object placed into the hand. However, the participant must report that they have no functional use of their hand(s).

Subjects must report that they are unable to perform functional activities with the hand contralateral to implantation.

Subjects must be over 1 year post-injury at time of implantation. In addition, subject must report no worsening in neurologic status (strength, sensation) for the previous 6 months.

Subjects must be between the ages of 22-70 years old at the time of enrollment and completion of the study. Participants outside this age range may be at an increased surgical risk and increased risk of fatigue during BMI training.

Subjects must live within 2 hours of the research site during the study or be willing to travel to the research site at least once per week for BMI training.

If subjects do not live in the area, they are expected to stay somewhere within 2 hours of the research site for at least 18 months after enrollment.

Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.

Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators

Subjects must have results that are within normal limits on neuropsychological and psychosocial assessment; psychosocial health and support will be assessed by interview with the psychologist.

Subjects must be able to activate distinct cortical areas during imagined or attempted movement tasks (i.e. hand movement and speaking or moving the mouth); this will be evaluated with functional magnetic resonance imaging (fMRI) as part of screening.

Subjects must have a stable psychosocial support and caregivers who are able to perform the necessary daily care of the participant's skin and pedestal site. This requires that the subject identify a caregiver and a backup who have been in place for greater than 6 months and are able to provide needed physical and psychosocial support. This will be assessed by the sponsor-investigator and study neurosurgeon.

Subjects must have a life expectancy greater than 18 months as assessed by the study investigator and neurosurgeon sub-investigator

Documentation of informed consent must be obtained from the participant or their legal representative.

Participants with transhumeral amputation must have been evaluated for a prosthesis, and if deemed appropriate, were fit with an optimized prosthesis. The prosthesis should be used/considered for the PROMIS evaluation.

Exclusion Criteria

Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses

Another serious disease(s) or disorder(s) that could affect ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status)

Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest

Metallic implant(s) that would prohibit the subject from having an fMRI scan; spinal fixators are generally non-ferrous and would not exclude someone from participating in the study

Any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve stimulator, or defibrillator

Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months

Allergy to contrast medium or kidney failure that could be exacerbated by contrast agent (for MRI)

Subjects receiving medications (such as sedatives) chronically that may retard motor coordination and cognitive ability

Individuals who require routine MRI, therapeutic ultrasound, or diathermy

Individuals with osteomyelitis

Severe skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp

History of myocardial infarction or cardiac arrest or with intractable cardiac arrhythmias

Individuals with an implanted hydrocephalus shunt

Individuals who have had a stroke caused by a surgical procedure

Active infection(s) or unexplained fever (verified during pre-op anesthesia evaluation to determine surgical risk status)

Consumption of more than 1 alcoholic beverage per day on average

Receiving chronic oral or intravenous steroids or immunosuppressive therapy

Active cancer within the past year (other than adequately treated basal cell or squamous cell skin cancer) or require chemotherapy

Uncontrolled insulin dependent diabetes mellitus

Uncontrolled autonomic dysreflexia within the past 3 months (for those with spinal cord injury)

Individuals with seizure disorders currently being treated with anti-epileptic medications and individuals with a familial history of seizure disorders

Individuals who have attempted suicide in the past 12 months

Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer, Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies, DiGeorge syndrome, HIV/AIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome)

Individuals who have had previous neurosurgical intervention involving the frontal lobes (especially the motor cortex) and/or parietal lobe (especially the somatosensory cortex) that is likely to impact the viability of an intracortical electrode

Individuals with active psychiatric concerns, including but not limited to major depression, bipolar disorder, schizophrenia or other psychotic disorder and post-traumatic stress disorder

Individuals with substance abuse within 6 months of study participation

Individuals who are judged by a clinician as being an unsafe ambulator - This would be decided based on a history of frequent uncontrolled falls more than 3 or 4 in a year, or falls that resulted in injury

Individuals who plan to participate in contact sports or sports that require a helmet

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 Chicago?

Yes, this clinical trial (NCT01894802) has an active research site in Chicago, IL 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 Chicago, IL

If you're searching for tetraplegia treatment options in Chicago, IL, this clinical trial (NCT01894802) 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 Chicago 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.

Tetraplegia Clinical Trial in Chicago, IL

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About This Tetraplegia Study in Chicago