ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis

University of Pittsburgh

Status: Completed

Conditions: ALS; Tetraplegia; Brainstem Stroke; Brachial Plexus Injury; Muscular Dystrophy; Spinal Cord Injury

Treatments: Device: Implantation of ECoG sensors on the brain surface

Study type: Interventional

Funder types: Other

Identifiers

NCT01393444

PRO10010149

Details and patient eligibility

About

The purpose of this research study is to demonstrate that individuals with upper limb paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis and brain stem stroke can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.

Full description

Brain-computer interface (BCI) technology aims to establish a direct link for transmitting information between the brain and external devices, offering a natural and rich control signal for prosthetic hands or functional electrical stimulators (FES) to re-animate paralyzed hands. This study focuses on an ECoG-based BCI system. ECoG measures brain activity using electrodes implanted on the surface of the brain. Each participant will undergo testing of the ECoG direct brain interface for up to 29 days. Participants will learn to control computer cursors, virtual reality environments, and assistive devices such as hand orthoses and functional electrical stimulators using neural activity recorded with the ECoG sensor.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Limited or no ability to use both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases
• At least 1 year post-injury
• Live within 1 hour of the University of Pittsburgh or willing to stay in Pittsburgh while the ECoG electrode is implanted (up to 29 days)
• Additional inclusion criteria must also be reviewed

Exclusion criteria

• Certain implanted devices
• Presence of other serious disease or disorder that could affect ability to participate in this study
• Additional exclusion criteria must also be reviewed

Trial design

6 participants in 1 patient group

Direct Brain Interface Users

Experimental group

Description:

All participants enrolled in the study will undergo "Implantation of ECoG sensors on the brain surface" to record neural activity. There is no control group. There are no other arms.

Treatment:

Device: Implantation of ECoG sensors on the brain surface