Recruiting

BrainGate2

Sponsor:

Leigh R. Hochberg, MD, PhD.

Code:

NCT06511934

Conditions

Brainstem Stroke

ALS

Tetraplegia

Spinal Cord Injuries

Cervical Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BrainGate Neural Interface System

Study Details

Brief summary:

People with brainstem stroke, advanced amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), or other disorders can become unable to move or speak despite being awake and alert. In this project, the investigators seek to further translate knowledge about interpreting brain signals related to movement, and to further develop an intracortical brain-computer interface (iBCI) that could restore rapid and intuitive use of communication apps on tablet computers by people with paralysis.

Conditions

Brainstem Stroke

ALS

Tetraplegia

Spinal Cord Injuries

Cervical Spinal Cord Injury

Study ID

NCT06511934

Start date

Jul 22, 2024

Status verified date

Jun, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
  • Complete or incomplete tetraplegia (quadriplegia)
  • Must live within a three-hour drive of the Study site
  • Prior enrollment in BrainGate2 clinical trial (NCT00912041)

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

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: BrainGate Neural Interface System

Device: BrainGate Neural Interface System

Interventions

BrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.

Primary outcome measure

  • Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Leigh R Hochberg, MD, Ph.D

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

Locations

Masssachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Leigh R Hochberg, MD, PhD

617-724-9247clinicaltrials@braingate.org

More Information

Sponsor

Leigh R. Hochberg, MD, PhD.

Last update posted

Jun 25, 2026

Last verified

Jun, 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 2026-06-25.