Using a neural interface to help people with tetraplegia control devices with their thoughts

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 Neural Interface System, which allows individuals with tetraplegia to control a computer cursor and other assistive devices using their thoughts. Participants will be individuals diagnosed with amyotrophic lateral sclerosis (ALS) who experience severe speech impairment. The study will assess the device's ability to restore certain abilities that are typically reliant on hand movement or speech. The research is conducted at prominent medical institutions to ensure rigorous evaluation and oversight.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Between 18 and 80 years of age.
* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

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

• Stanford University School of Medicine
  Stanford, California, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Jaimie Henderson, MD — Stanford University
• Study coordinator: Leigh R Hochberg, MD, Ph.D
• Email: lhochberg@mgh.harvard.edu
• Phone: 617-724-9247

Similar studies

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

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• Feasibility of a brain-computer interface for people with tetraplegia

  This study is testing a new brain-computer interface that helps people with tetraplegia control a computer and other devices just by thinking, to see if it’s safe and effective.

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• Investigation of a brain-computer interface system for communication in patients with severe disabilities

  This study is testing a new brain-computer interface that helps people with severe disabilities, like tetraplegia and ALS, communicate better by using signals from their brain.

  Recruiting Johns Hopkins University · Baltimore, Maryland · NCT03567213

• Decoding Mandarin speech features from brain-surface signals

  This project will try to decode imagined Mandarin speech, including lexical tones, from high-density brain-surface (ECoG) signals in adult patients who are having clinically indicated cortical electrode placement.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07460037

• Connexus® Brain-Computer Interface to restore communication and device control

  This study will try the Connexus brain-computer interface to help people with severe loss of voluntary movement (for example from ALS, cervical spinal cord injury, or stroke) communicate and control computers.

  Recruiting at 3 sites Paradromics · Sacramento, California and 2 other locations · NCT07357428

• Using a brain-computer interface to help people with tetraplegia communicate

  This study is testing a new brain-computer interface to help people with tetraplegia communicate more easily using a tablet.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT06511934

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.