United States ALS and other Motor Neuron Diseases Trial

The goal of the first phase of the BrainGate clinical study in ALS (Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease) and other motor neuron diseases is to demonstrate the System's ability of the BrainGate System to record the participants' neural activity and to provide direct control of a computer signal by thought. Another goal of the study is to combine the use the participant’s ability to us a thought-controlled computer signal for the operation of communication software.

Individuals with motor impairments due to ALS or another from of motor neuron disease are being recruited into a clinical study at Massachusetts General Hospital (MGH). Clinical trial participants must live within a two-hour drive of Boston. Final eligibility for participation in the clinical study is determined by the Principal Investigators, who are licensed Medical Doctors.

Investigators in the trial are:

Leigh Hochberg, M.D., Ph.D. -- Dr. Hochberg is the Principal Investigator for the feasibility study of the BrainGate System in persons with ALS or other forms of motor neuron disease. Dr. Hochberg was a key contributor to the creation of the clinical Protocol for the current trial. He received his M.D. and Ph.D. degrees from Emory University. He completed his neurology residency and was a Chief Resident at MGH and Brigham & Women’s Hospitals (BWH). Dr. Hochberg is trained in stroke/neurocritical care, is on the Neurology staff at MGH and BWH, and consults at the Spaulding Rehabilitation Center.

Robert Brown, Jr., M.D., D. Phil. – Dr. Brown is Professor of Neurology at Harvard Medical School, a member of the Institute of Medicine and Director of the Day Neuromuscular Laboratory and Muscular Dystrophy Association clinic at Massachusetts General Hospital (MGH). The Day Laboratory of Neuromuscular Research was founded in 1984 by Dr. Brown and has become an internationally recognized center for research and clinical care in neuromuscular diseases.

Merit Cudkowicz, M.D. – Dr. Cudkowicz is an Associate Professor at Harvard Medical School. She is trained in Neurology and Experimental Therapeutics with a focus in neurodegenerative disorders. Dr. Cudkowicz is an Associate Professor at Harvard Medical School. Dr. Cudkowicz co-directs the MGH ALS clinic and the Neurology Clinical Trials Unit at MGH and Partners HealthCare System. She is leading several multi-center clinical trials in ALS.

Lisa Krivickas, M.D. – Dr. Krivickas is Associate Chief of Physical Medicine & Rehabilitation at MGH and practices at the Spaulding Rehabilitation Hospital. She received her M.D. degree from Harvard University and completed her Physical Medicine & Rehabilitation Fellowship at the Department of Neurology at Cleveland Clinic. She currently serves on the Board of scientific advisors for the Massachusetts ALS Association Chapter.

Enrollment in the pilot trial is currently underway at the Massachusetts General Hospital in Boston.

View a BrainGate System educational animation by clicking here.