Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Leigh R. Hochberg, MD, PhD.
Study ID
NCT06511934
Status
Recruiting
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Conditions

  • ALS
  • Brainstem Stroke
  • Cervical Spinal Cord Injury
  • Spinal Cord Injuries
  • Tetraplegia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • BrainGate Neural Interface System — DEVICE
    Placement of the BrainGate2 sensor(s) into arm-hand motor-related cortex.

Study Details

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.

Key Dates

Start date
Jul 22, 2024
Status verified
Nov 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2027

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: BrainGate Neural Interface System
    Device: BrainGate Neural Interface System

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

Locations (1)

FacilityCityStateZIPSite coordinators
Masssachusetts General HospitalBostonMassachusetts02114
Leigh R Hochberg, MD, PhD
[email protected]
617-724-9247

Find similar trials in Boston, MA

By research site
Masssachusetts General Hospital· Boston, MA

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