Recruiting

BrainGate2

Sponsor:

Leigh R. Hochberg, MD, PhD.

Code:

NCT06094205

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 goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

Conditions

Anarthria

Dysarthria

Tetraplegia

Spinal Cord Injuries

Amyotrophic Lateral Sclerosis

Study ID

NCT06094205

Start date

Oct 16, 2023

Status verified date

Nov, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 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
  • 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 and geographically stable for at least 15 months after enrollment.

(There are additional inclusion criteria)

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

2 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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

  • 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, M.D., Ph.D.

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

Sergey Stavisky, Ph.D.

530-754-3413sstavisky@ucdavis.edu

Locations

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

David M Brandman, M.D.

916-703-5010dmbrandman@ucdavis.edu

Sergey Stavisky, Ph.D

530-754-3413sstavisky@ucdavis.edu

More Information

Sponsor

Leigh R. Hochberg, MD, PhD.

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

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 2025-12-01.