RecruitingNot ApplicableNCT01894802

Cortical Recording and Stimulating Array Brain-Machine Interface

A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment


Sponsor

Michael Boninger

Enrollment

30 participants

Start Date

Dec 1, 2013

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a brain-machine interface (BMI) — a device implanted in the brain that reads nerve signals and translates them into commands to restore hand and arm movement for people with paralysis. The goal is to allow people who have lost the use of their hands to control robotic devices, computer cursors, or their own limbs through thought alone. You may be eligible if... - You are between 22 and 70 years old - You have limited or no ability to use one or both hands due to spinal cord injury, stroke, amputation, or other qualifying conditions - You are more than 1 year post-injury with no recent worsening - You can communicate in English - You have stable psychosocial support and a reliable caregiver - You live within 2 hours of the research site and can travel regularly for training - Brain imaging (fMRI) confirms you can activate distinct areas during imagined movements You may NOT be eligible if... - You have a pacemaker, cochlear implant, deep brain stimulator, or other implanted electronic device - You are pregnant or plan to become pregnant during the study - You have active cancer, uncontrolled diabetes, or active infections - You have a history of seizures, myocardial infarction, or psychiatric disorders - You have a hydrocephalus shunt or history of brain surgery in relevant areas - You drink more than 1 alcoholic beverage per day on average - You have attempted suicide in the past 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantation of CRS Arrays

Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex of study participants.


Locations(2)

University of Chicago

Chicago, Illinois, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT01894802


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