Study Purpose:The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Anarthria , Dysarthria , Tetraplegia , Spinal Cord Injuries , Amyotrophic Lateral Sclerosis , Brain Stem Infarctions , Locked in Syndrome , Muscular Dystrophies
Type of Intervention:
BrainGate Neural Interface System
Study Chair(s)/Principal Investigator(s):
Jaimie Henderson, MD, Stanford University
Coordinating Center Contact Information
Full Study Summary:
Leigh R. Hochberg, MD, PhD.
Estimated Study Start Date:
03 / 21 / 2023
Estimated Study Completion Date:
12 / 01 / 2026
Posting Last Modified Date:
04 / 05 / 2023
Date Study Added to neals.org:
02 / 13 / 2023
75 YearsInclusion Criteria:
- Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
- Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
1. Between 18 and 75 years of age.
2. The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication.
3. Complete or incomplete tetraplegia (quadriplegia)
4. A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening.
5. Per clinical opinion, a life expectancy of greater than 6 months.
6. Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.
(There are additional exclusion criteria)
Stanford University School of Medicine | Recruiting
Principal Investigator : Jaimie Henderson, M.D.
Massachusetts General Hospital | Recruiting
Sub-Investigator : Daniel B Rubin, M.D., Ph.D.