NCT01894802

Cortical Recording and Stimulating Array Brain-Machine Interface

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Michael Boninger · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Individuals with severe paralysis have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural (nerve) signals are generated even though they do not reach the arms, hands and legs. By placing (implanting) sensors on the surface of the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays. Using neural activity to control an external device is referred to as a brain-machine interface (BMI) technology. In addition, areas of the brain that are involved in interpreting sensations from the arms, hands and legs remain functional after injury. It is therefore possible to send tiny electrical pulses through implanted arrays to mimic sensory input that would normally come from the arms, hands and legs. The investigators refer to this as "microstimulation."

Conditions

• Tetraplegia
• Spinal Cord Injury
• Brainstem Stroke
• Brachial Plexus Injury
• Above Elbow Amputation

Interventions

Type	Name	Description
DEVICE	Implantation of CRS Arrays	Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex of study participants.

Timeline

• Start date: 2013-12-01
• Primary completion: 2027-08-01
• Completion: 2029-12-01
• First posted: 2013-07-10
• Last updated: 2025-10-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study