Your session is about to expire
← Back to Search
Neural Prosthetic System
Brain-Machine Interface for Quadriplegia
N/A
Recruiting
Led By Luke Bashford, PhD
Research Sponsored by Richard A. Andersen, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 22-65
High cervical spinal lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year after array implantation
Awards & highlights
Study Summary
This trial is being conducted to study a new brain-machine interface that may help people with spinal cord injuries control a computer or robotic limb.
Who is the study for?
This trial is for individuals aged 22-65 with high spinal cord injuries resulting in quadriplegia, who can communicate in English and follow instructions. They must have a support system, be able to travel to the study site frequently, and have someone to monitor them daily post-surgery. Exclusions include memory or psychiatric disorders, poor vision, certain infections or cancers, diabetes, seizures history, MRI contraindications among others.Check my eligibility
What is being tested?
The trial tests a brain-machine interface called Neural Prosthetic System 2 (NPS2), which involves implanting electrodes into the brain to allow control of devices like robotic limbs using thoughts and sensory feedback. The safety and effectiveness of this experimental device will be evaluated.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode implantation sites on the scalp visible as small protrusions that can be covered by a hat or scarf. There's also a risk associated with surgical procedures such as infection or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 65 years old.
Select...
I have a high spinal cord injury in my neck.
Select...
I can talk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year after array implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year after array implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absence of infection or irritation
Patient control over the end effector (virtual or physical)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neural Prosthetic System 2Experimental Treatment1 Intervention
The Neural Prosthetic System 2 consists of three Neuroport Arrays, which are described in detail in the intervention description. Two of the three Neuroport Arrays are inserted into the posterior parietal cortex, an area of the brain used in reach and grasp planning. The third Neuroport Array is inserted into somatosensory cortex, specifically S1 which represents sensory feedback for the hand and fingers. The arrays are inserted and the percutaneous pedestal is attached to the skull during a surgical procedure. Following surgical recovery the subject will participate in study sessions 3-5 times per week in which they will learn to control an end effector by thought augmented with sensory feedback via intracortical microstimulation. They will then use the end effector to perform various reach and grasp tasks.
Find a Location
Who is running the clinical trial?
Richard A. Andersen, PhDLead Sponsor
2 Previous Clinical Trials
3 Total Patients Enrolled
2 Trials studying Quadriplegia
3 Patients Enrolled for Quadriplegia
University of Southern CaliforniaOTHER
909 Previous Clinical Trials
1,601,455 Total Patients Enrolled
1 Trials studying Quadriplegia
1 Patients Enrolled for Quadriplegia
Rancho Los Amigos National Rehabilitation CenterOTHER
7 Previous Clinical Trials
1,860 Total Patients Enrolled
1 Trials studying Quadriplegia
1 Patients Enrolled for Quadriplegia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing chemotherapy or have active cancer.I have diabetes.I have had seizures in the past.You have a shunt for hydrocephalus.I am between 22 and 65 years old.My caregiver checks me daily for surgery complications and changes in my behavior.You have difficulty remembering things.I have health issues that prevent me from having surgery or getting a long-term medical device.I have had surgery to repair my skull.I am not on long-term steroids or drugs that weaken my immune system.You have thoughts of hurting yourself.You have a problem with drugs or alcohol.I currently have an infection or unexplained fever.I have sores or broken skin on my scalp.I am living with HIV/AIDS.I can travel up to 60 miles for the study 5 days a week.I have a high spinal cord injury in my neck.I cannot have an MRI or might need one during the study.I have had brain surgery that affected the function of my parietal lobe.You have access to emotional and mental support.You have a deep brain stimulator, DBS leads, or cochlear implant.I experience sudden high blood pressure due to a spinal cord injury.You have a device implanted in your body to help control your heart or nerves.I am cleared by a doctor to undergo surgery.You are expected to live for more than 12 months.I have an intellectual disability.You have trouble seeing clearly.I can talk.I do not have untreated major depression or chronic psychiatric disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Neural Prosthetic System 2
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.
Are geriatric patients eligible for this research endeavor?
"Patients who meet the age criteria of being more than 22 years old and less than 65 are eligible for recruitment into this clinical trial."
Answered by AI
To whom is participation in this clinical research experiment available?
"This clinical trial is accepting applications from people between 22 and 65 years old who suffer with quadriplegia. There are up to 2 vacancies available."
Answered by AI
Are there still vacancies for individuals to partake in this research?
"Affirmative. Clinicaltrials.gov has revealed that this trial is still searching for participants, which was first announced on November 1st 2013 and last refreshed on May 27th 2022. The research team needs two individuals to volunteer from one medical institution."
Answered by AI
How many participants are actively involved in this research?
"Affirmative. Clinicaltrials.gov states that this medical trial is presently recruiting participants, with the first post dated November 1st 2013 and last modified on May 27th 2022. The study desires to engage 2 patients from one research centre."
Answered by AI
Who else is applying?
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
interested in new tech for SCI.
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger