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Brain-Machine Interface
CRS Array Brain-Machine Interface for Spinal Cord Injury (CRS-BMI Trial)
N/A
Recruiting
Led By Michael L Boninger, MD
Research Sponsored by Michael Boninger
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects 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
Subjects must be over 1 year post-injury at time of implantation and report no worsening in neurologic status for the previous 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year following array implantation
Awards & highlights
CRS-BMI Trial Summary
This trial is testing if two implantable devices are safe and effective for long-term recording of brain activity and stimulation of sensation.
Who is the study for?
This trial is for adults aged 22-70 with severe hand function loss due to specific injuries or conditions, able to follow study procedures and communicate in English. They must have a stable support system, live within 2 hours of the University of Pittsburgh, and not have worsening neurological status. Excluded are those with visual impairments, active infections, excessive alcohol consumption, certain diseases that affect participation ability, metal implants incompatible with MRI scans, uncontrolled diabetes or seizures.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of CRS Arrays (microelectrodes) implanted in the brain. These devices record motor cortex activity and stimulate sensory cortex to potentially restore movement control or sensation in individuals with severe upper limb disabilities.See study design
What are the potential side effects?
Potential side effects may include discomfort at implant sites, risk of infection from surgery, possible skin irritation around care areas for the device pedestal. There might also be risks associated with long-term brain stimulation such as changes in mood or sensations.
CRS-BMI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hand strength is weak and my arm function scores are low on the opposite side of my planned implant.
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It's been over a year since my injury, and my condition hasn't worsened in the last 6 months.
Select...
I am between 22 and 70 years old.
Select...
I live within 2 hours of the University of Pittsburgh or can travel there weekly.
Select...
I can communicate in English with the study team.
Select...
I have limited or no use of one or both hands due to an injury or condition.
CRS-BMI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year following array implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year following array implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The is the safety of the participant.
Secondary outcome measures
The is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices.
CRS-BMI Trial Design
1Treatment groups
Experimental Treatment
Group I: Brain-Machine Interface UsersExperimental Treatment1 Intervention
All participants enrolled in the study who meet eligibility criteria will be individuals implanted with microelectrodes in their brain to record neural activity. There is no control group.
Find a Location
Who is running the clinical trial?
University of ChicagoOTHER
1,003 Previous Clinical Trials
819,719 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
917,201 Total Patients Enrolled
1 Trials studying Quadriplegia
61 Patients Enrolled for Quadriplegia
Carnegie Mellon UniversityOTHER
76 Previous Clinical Trials
539,900 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have trouble seeing things on a computer screen even with glasses.You have metal implants that would prevent you from having an fMRI scan.You have any kind of implantable device like a pacemaker, cochlear implant, or defibrillator.You need to have regular MRI, therapeutic ultrasound, or diathermy treatments.You drink more than one alcoholic beverage every day on average.You have experienced uncontrolled autonomic dysreflexia in the past 3 months.You have tried to harm yourself in the last 12 months.You are currently dealing with significant mental health issues like depression, bipolar disorder, schizophrenia, or post-traumatic stress disorder.You are expected to live for more than 18 months.I have had cancer or needed chemotherapy in the last year.I understand the study's goals and can follow simple instructions.I have reliable support for daily skin and pedestal site care.I have an upper arm amputation and have been fitted with a prosthesis if deemed suitable.You need to have normal results on tests for thinking and emotions.You need to be able to activate different parts of your brain when thinking about or trying to move.I have had pressure sores that might worsen with 1-2 days in bed.I am not pregnant, breastfeeding, nor planning to become pregnant in the next 25 months.I am allergic to contrast dye or have kidney issues that contrast dye could worsen.I am on medication that affects my movement or thinking.I have had a heart attack, cardiac arrest, or uncontrollable heart rhythm problems.I had a stroke resulting from surgery.I currently have an infection or a fever without a known cause.I am currently taking long-term steroids or medications that suppress my immune system.I have diabetes that is not well-controlled with insulin.A doctor considers me unsafe to walk on my own.I am on medication for seizures or have a family history of seizures.I plan to participate in contact sports or sports requiring a helmet.My hand strength is weak and my arm function scores are low on the opposite side of my planned implant.It's been over a year since my injury, and my condition hasn't worsened in the last 6 months.I am between 22 and 70 years old.I live within 2 hours of the University of Pittsburgh or can travel there weekly.I can communicate in English with the study team.I have a weakened immune system due to a condition or treatment.I've had brain surgery on the frontal or parietal lobes that might affect an electrode's placement.I have limited or no use of one or both hands due to an injury or condition.You have used drugs or alcohol excessively in the last 6 months.You have a medical device called a hydrocephalus shunt implanted in your body.I do not have any serious illnesses that would stop me from joining this study.I have been diagnosed with osteomyelitis.I have a severe skin condition affecting my scalp.
Research Study Groups:
This trial has the following groups:- Group 1: Brain-Machine Interface Users
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity of participants in this research project?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively seeking participants and was initially posted on December 1st 2013. The last update occurred on September 22nd 2022 - 30 volunteers are necessary at a single site for the study's completion."
Answered by AI
What demographic is most likely to benefit from participating in this research?
"We are presently enrolling 30 individuals with Weber Syndrome between the ages of 22 and 70. Eligible participants must meet several criteria for inclusion, including but not limited to: residing within a two-hour radius of Pittsburgh University or having no qualms about travelling there weekly; being at least one year post injury; displaying proficiency in English due to study instructions; evincing minimal finger flexor strength on the contralateral side to implantation combined with low T-Score on PROMIS Upper Extremity Short Form; demonstrating an inability to effectively use their hand(s) while still able to engage passively when required; exhibiting normal neuropsych"
Answered by AI
Are geriatric patients capable of participating in this research project?
"This experiment is open to participants between the ages of 22 and 70 years."
Answered by AI
Are there any remaining vacancies for patients to join this trial?
"Yes, according to clinicaltrials.gov the trial is still recruiting patients, having been published on December 1st 2013 and most recently updated on September 22nd 2022. This study needs 30 participants from a single medical centre."
Answered by AI
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