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New treatment option for Tetraplegia
Official title Cortical Recording and Stimulating Array Brain-Machine Interface
ClinicalTrials.gov ID: NCT01894802
What this study is testing
- What it's testing
- The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- people must have limited or no ability to use one or both hands due to cervical spinal cord injury, brainstem stroke, brachial plexus injury...
- people must report that they are unable to perform functional activities with the hand contralateral to implantation.
- people must be over 1 year post-injury at time of implantation. In addition, subject must report no worsening in neurologic status (strength...
- people 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...
- people 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...
You likely can't join if
- 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...
- 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...
- Any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve...
- Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months
See the full eligibility criteria
Who can join
- people 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...
- people must report that they are unable to perform functional activities with the hand contralateral to implantation.
- people 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.
- people 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...
- people 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 people 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.
- people must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
- people must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators
- people 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.
- people 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...
- people 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...
- people 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.
What rules you out
- 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)
- people 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Pittsburgh, Pennsylvania, United States
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, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Pittsburgh, Pennsylvania, United States. 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.