RecruitingNot Applicable

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

United States27 participantsStarted 2009-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * (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)

What they're measuring

The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.

Timeframe: One year post-implant evaluation period

Trial details

NCT IDNCT00912041

SponsorLeigh R. Hochberg, MD, PhD.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2038-09

Contact for this trial

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

617-724-9247 clinicaltrials@braingate.org

View on ClinicalTrials.gov More Tetraplegia trials