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Brain-Machine Interface for Paralysis
N/A
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgical clearance
Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six years after array implantation
Awards & highlights
Study Summary
This trial is developing a technology to help paralyzed people control a computer with their brain, using four chips to decode meaningful information from brain activity. It can help with multiple applications, and could greatly improve the autonomy and quality of life for those affected. Two people are taking part in the study for up to 6 years.
Who is the study for?
This trial is for severely paralyzed individuals with a life expectancy over 12 months, who can follow instructions and travel to the study site regularly. They must have paralysis due to cervical SCI, brainstem stroke, or ALS. Excluded are those with memory issues, intellectual impairments, certain medical conditions or devices that conflict with surgery or MRI use.Check my eligibility
What is being tested?
The MindEx system uses four implanted brain 'chips' to decode thoughts into computer control signals. This single-arm study tests its safety and effectiveness in allowing users to operate applications like word processors and games on a computer interface.See study design
What are the potential side effects?
Potential side effects may include surgical site complications monitored by caregivers and behavioral changes due to the implantation of the device. The long-term impact of having chips implanted in multiple brain regions will be closely studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am cleared by a doctor for surgery.
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I have paralysis due to a spinal cord injury, stroke in the brainstem, or ALS.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: annually, for six years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: annually, for six years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Competency in computer/tablet control
Continuous trajectory decoding
Efficacy of multiple brain regions for neural control over subsets of brain regions
+1 moreSecondary outcome measures
Change in quality of life
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mind Extender (MindEx)Experimental Treatment1 Intervention
MindEx consists of two Neuroport Multi-Port Arrays, described in detail in the intervention description. Each NeuroPort Multi-Port Array comprises two electrode arrays implanted into human brain tissue, for a total of four electrode arrays. These will be in 1) prefrontal cortex, a brain area involved in scene comprehension, action selection, and error signaling, 2) premotor cortex, a brain area involved in planning ongoing and upcoming actions, 3) posterior parietal cortex, a brain area involved in processing sensory-to-motor transformations during movements, and 4) primary motor cortex, responsible for controlling movement. The pair of electrode arrays in each NeuroPort Multi-Port Array connect to a single percutaneous pedestal attached to the skull during a surgical procedure. Following recovery from the surgical placement, subjects will participate in study sessions up to 5 times a week. They will learn to use thought to control applications on a computer, a laptop, or a tablet.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,797 Total Patients Enrolled
Srinivas ChivukulaLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have health issues that prevent me from having surgery or getting a long-term medical device.You have a support system to help with your emotions and mental well-being.I am not on long-term steroids or drugs that weaken my immune system.You have a shunt for hydrocephalus.You have thoughts about harming yourself.I am currently undergoing chemotherapy or have active cancer.You have a condition called autonomic dysreflexia.I have had seizures in the past.You cannot have an MRI or may need to have an MRI during the study.My caregiver checks me daily for surgery complications and changes in my behavior.I am cleared by a doctor for surgery.You have memory issues.I have been diagnosed with an intellectual impairment.I have poor eyesight.I am living with HIV/AIDS.I have had surgery to repair my skull.You have a problem with using drugs or alcohol.I can communicate verbally or through other methods.I do not have untreated major depression or chronic psychiatric disorders.You are expected to live for at least 12 more months.I have lesions or open wounds on my scalp.I have diabetes.I can travel to the study site up to five days a week for the study duration.I currently have an infection or unexplained fever.I have paralysis due to a spinal cord injury, stroke in the brainstem, or ALS.
Research Study Groups:
This trial has the following groups:- Group 1: Mind Extender (MindEx)
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.
Who meets the criteria to participate in this experiment?
"To partake in this clinical trial, individuals must have quadriplegia and be between 18-65 years of age. At present, approximately 2 participants are being recruited."
Answered by AI
Are those aged thirty and above eligible to partake in this trial?
"This clinical trial is open to those between the ages of 18 and 65. For minors or elderly individuals, there are 49 trials and 51 studies respectively available for them to enrol in."
Answered by AI
Is this experiment still recruiting new participants?
"Unfortunately, this medical trial is no longer enrolling participants. It was initially posted on September 1st 2023 and the last update occurred on July 3rd of that year. However, 94 separate trials are presently recruiting individuals at this time."
Answered by AI
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