Functional Neurosurgery Clinical Trials

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Stanford NPTL is part of the BrainGate Clinical Trial, "BrainGate2: Feasibility study of an intracortical neural interface system for people with tetraplegia." (Sponsor and PI: Leigh Hochberg, MD, PhD; Clinical Trials.gov: NCT00912041).  The purpose of the first phase of the pilot clinical study of the BrainGate2 Neural Interface System is to obtain preliminary device safety information and to demonstrate the feasibility of people with tetraplegia using the System to control a computer cursor and other assistive devices with their thoughts. Another goal of the study is to determine the participants’ ability to operate communication software, such as e-mail, simply by imagining the movement of their own hand. The study is invasive and requires surgery.  Individuals with limited or no ability to use both hands due to cervical spinal cord injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases are being recruited into a clinical study at Massachusetts General Hospital (MGH), Stanford University and Case Western Reserve University. Clinical trial participants must live within a three-hour drive of Boston, MA, Palo Alto, CA or Cleveland, OH.  Clinical trial sites at other locations may be opened in the future. The study requires a commitment of 13 months.

Deep Brain Stimulation for the Treatment of Traumatic Brain Injury

This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through an implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.

Stanford is currently not accepting patients for this trial.  

NCT02881151