CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 27 target
Drug / intervention
Placement of the BrainGate2 sensor(s) into the motor-related cortexdevice
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, ALS or other motor neuron disorders
  • ✓Complete or incomplete tetraplegia (quadriplegia)
  • ✓Must live within a three-hour drive of the Study site
Key exclusion· 3
  • ✕Visual impairment making extended computer monitor viewing difficult even with 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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00912041
NCT00912041N/ARecruitingOn Track
Long Recruiting
CompareCT.gov

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Leigh R. Hochberg, MD, PhD.·interventional·Posted Jun 3, 2009·Updated Jun 1, 2026

In Brief

A clinical study evaluating Placement of the BrainGate2 sensor(s) into the motor-related cortex for Tetraplegia and 5 related conditions. Currently recruiting, targeting 27 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy
CountriesUnited States
CollaboratorsNational Institute on Deafness and Other Communication Disorders (NIDCD), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)

Timeline

N/ARecruiting
2009201020112012201320142015201620172018201920202021202220232024202520262027202820292030203120322033203420352036203720382039
First PostedJun 3, 2009
Enrollment StartMay 1, 2009
Primary CompletionSep 1, 2038
Study CompletionDec 1, 2038
TodayJul 2, 2026
Enrollment to primary: 29.3 yearsPosted 17.1 years agoPrimary completion in 12.2 years

Interventions

Placement of the BrainGate2 sensor(s) into the motor-related cortexdevice

Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.