Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

Leigh R. Hochberg, MD, PhD.

Status

Enrolling

Conditions

ALS

Tetraplegia

Brainstem Stroke

Spinal Cord Injuries

Cervical Spinal Cord Injury

Treatments

Device: BrainGate Neural Interface System

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06511934

U01DC017844 (U.S. NIH Grant/Contract)

2009P000505 (BG-Tablet-01)

Details and patient eligibility

About

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Full description

The goal of this project is to advance the methods by which people with tetraplegia can gain intuitive, reliable control of communication apps on industry-standard tablet computers through use of an intracortical brain-computer interface (iBCI).

Enrollment

2 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
Complete or incomplete tetraplegia (quadriplegia)
Must live within a three-hour drive of the Study site
Prior enrollment in BrainGate2 clinical trial (NCT00912041)

Exclusion criteria

Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
Chronic oral or intravenous steroids or immunosuppressive therapy
Other serious disease or disorder that could seriously affect ability to participate in the study

(There are additional exclusion criteria)