Feasibility of a brain-computer interface for people with tetraplegia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and feasibility of the BrainGate2 intracortical neural interface system, which allows individuals with tetraplegia to control a computer cursor and assistive devices using their thoughts. Participants will have sensors implanted in the motor-related cortex to facilitate this control. The research focuses on developing a medical device that can help restore abilities typically reliant on hand movement or speech for those with severe paralysis. The study will gather preliminary data on device performance and user experience.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of California, Davis
  Sacramento, California, United States Recruiting
• Stanford University School of Medicine
  Stanford, California, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Providence VA Medical Center
  Providence, Rhode Island, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Leigh R Hochberg, M.D., Ph.D. — Massachusetts General Hospital
• Study coordinator: Leigh R Hochberg, M.D., Ph.D.
• Email: clinicaltrials@braingate.org
• Phone: 617-724-9247

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• A device to assist hand function for people with spinal cord injuries

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.