Recruiting

BrainGate2

Sponsor:

Leigh R. Hochberg, MD, PhD.

Code:

NCT05724173

Conditions

Anarthria

Dysarthria

Tetraplegia

Spinal Cord Injuries

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BrainGate Neural Interface System

Study Details

Brief summary:

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.

Conditions

Anarthria

Dysarthria

Tetraplegia

Spinal Cord Injuries

Amyotrophic Lateral Sclerosis

Study ID

NCT05724173

Start date

Oct 18, 2023

Status verified date

May, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between 18 and 80 years of age.
  • 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.
  • Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

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)

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Interventions

BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Primary outcome measure

  • Device Safety [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Leigh R Hochberg, MD, Ph.D

617-724-9247lhochberg@mgh.harvard.edu

Jaimie Henderson, MD

650-723-5574henderj@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Jaimie Henderson, M.D.

650-723-5574henderj@stanford.edu

Principal Investigator:

Jaimie Henderson, M.D.

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Leigh R Hochberg, MD, PhD

617-742-9247lhochberg@mgh.harvard.edu

Principal Investigator:

Leigh R Hochberg, M.D., Ph.D.

More Information

Sponsor

Leigh R. Hochberg, MD, PhD.

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Leigh R. Hochberg, MD, PhD. on 2026-06-02.