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.Study Status:
Recruiting
Disease:
Anarthria , Dysarthria , Tetraplegia , Spinal Cord Injuries , Amyotrophic Lateral Sclerosis , Brain Stem Infarctions , Locked in Syndrome , Muscular Dystrophies
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
BrainGate Neural Interface System
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jaimie Henderson, MD, Stanford University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Leigh R Hochberg, MD, Ph.D / email hidden; JavaScript is required / 617-724-9247
Full Study Summary:
The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.
Study Sponsor:
Leigh R. Hochberg, MD, PhD.
Estimated Enrollment:
2
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
Minimum Age:
18 Years
Maximum Age:
75 Years
Inclusion 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.
Exclusion Criteria:
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
Jaimie Henderson, M.D. / 650-723-5574 / email hidden; JavaScript is required
Principal Investigator : Jaimie Henderson, M.D.
Stanford, California
94305
United States
Massachusetts General Hospital | Recruiting
Leigh R Hochberg, MD, PhD / 617-742-9247 / email hidden; JavaScript is required
Sub-Investigator : Daniel B Rubin, M.D., Ph.D.
Boston, Massachusetts
02114
United States