Your session is about to expire
← Back to Search
Prosthetics
Visuomotor Prosthetic for Paralysis
N/A
Recruiting
Led By Ausaf Bari, MD, 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
A regular caregiver to monitor the surgical site
Pathology resulting in paralysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six years after array implantation
Awards & highlights
Study Summary
This trial is looking at whether or not a brain-chip can be used to provide communication capabilities to severely paralyzed individuals. Five subjects will be enrolled and implanted with the NCS for a period of up to six years.
Who is the study for?
This trial is for individuals aged 22-65 with paralysis, able to give consent and follow instructions, who live close to the study site. They must have a caregiver, a support system, stable ventilator status, and be expected to live more than a year. Excluded are those with HIV/AIDS, active cancer, certain brain injuries or conditions preventing surgery or MRI scans.Check my eligibility
What is being tested?
The trial tests a 'brain-chip' that lets severely paralyzed people control computers directly with their brain activity. Participants will learn to use this neural communication system over at least one year (up to six) to operate tablet computers for various tasks like making calls or controlling smart devices.See study design
What are the potential side effects?
Potential side effects may include discomfort from the implantation of the device, risk of infection at surgical sites monitored by caregivers, possible inflammation due to foreign body reaction in the brain tissue around the chip.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have someone to help me watch my surgery area.
Select...
I am paralyzed due to a medical condition.
Select...
I can talk.
Select...
I am between 22 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six years after array implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six years 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
Subject control of a tablet computer
Trial Design
1Treatment groups
Experimental Treatment
Group I: Neural Communication SystemExperimental Treatment1 Intervention
The Neural Communication System consists of two Neuroport Multi-Port Arrays, which are descried in detail in the intervention description. One Neuroport Multi-Port Array is inserted into the posterior parietal cortex, an area of the brain used in reach planning. The second Neuroport Multi-Port Array is inserted into the motor cortex, which is primarily responsible for controlling movement. 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 use thought to control a simple computer environment or a tablet computer.
Find a Location
Who is running the clinical trial?
Casa Colina Hospital and Centers for HealthcareOTHER
9 Previous Clinical Trials
299 Total Patients Enrolled
Richard A. Andersen, PhDLead Sponsor
2 Previous Clinical Trials
6 Total Patients Enrolled
2 Trials studying Quadriplegia
6 Patients Enrolled for Quadriplegia
University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,278,200 Total Patients Enrolled
1 Trials studying Quadriplegia
12 Patients Enrolled for Quadriplegia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have someone to help me watch my surgery area.I have an intellectual disability.I do not have untreated major depression or chronic psychiatric disorders.You have a shunt for treating hydrocephalus.I have had a brain injury or surgery above the cerebellum.You have a implanted heart device, nerve stimulator, or spinal cord stimulator.I am paralyzed due to a medical condition.I can talk.I currently have an infection or a fever without a known cause.I have sores or wounds on my scalp.I am living with HIV/AIDS.I am currently undergoing cancer treatment.My diabetes is not well-controlled with medication.I am between 22 and 65 years old.I experience sudden high blood pressure due to a spinal cord injury.I have had seizures in the past.I have health issues that make surgery or long-term device use unsafe.I cannot have an MRI or might need one during the study.I am not on long-term steroids or drugs that weaken my immune system.You are expected to live for more than 12 months.You have thoughts about hurting yourself.You have a system of support for your mental and emotional well-being.I am cleared by a doctor to undergo surgery.You have trouble seeing clearly.You are dependent on drugs or alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: Neural Communication System
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.
Is enrollment for this trial open to the public?
"According to the clinicaltrials.gov database, this medical trial is actively seeking participants and was first published on October 1st 2013 with the most recent edit being made April 5th 2022."
Answered by AI
What is the current enrollment size for this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this experimental trial is presently recruiting, which was originally posted on October 1st 2013 and updated lastly on April 5th 2022. Two participants from two sites are needed to partake in the research project."
Answered by AI
Are senior citizens being admitted to this clinical experiment?
"Eligible candidates for this trial must be between 22 and 65 years of age."
Answered by AI
To whom is this medical experiment open for participation?
"This research project requires 2 individuals with quadriplegia to participate, aged between 22 and 65. For consideration, applicants must fulfil the following conditions: they need surgical approval; be within 60 miles of the site; able to travel 5 days a week if necessary; capable of communicating through speech; have more than 12 months left in their life expectancy and have a robust psychosocial network."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger