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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

Recruiting
18-80 years
All
Phase N/A

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Overview

The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.

Description

The goal is to develop a new way to help people who lose the ability to speak due to neurological conditions including ALS or stroke, using an implanted medical device called a "brain-computer interface". The implanted medical device measures the person's brain activity as they try to talk and outputs their intended speech. By bypassing the injured parts of the nervous system this way, we can observe how individual brain cells are involved in speaking and working together as a network, to produce speech, and we can learn to decipher this activity to output what the person is trying to say.

Eligibility

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:

  • Between 18 and 80 years of age.
  • The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication.
  • Complete or incomplete tetraplegia (quadriplegia)
  • A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening.
  • Per clinical opinion, a life expectancy of greater than 6 months.
  • Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.

(There are additional exclusion criteria)

Study details
    Anarthria
    Dysarthria
    Tetraplegia
    Spinal Cord Injuries
    Amyotrophic Lateral Sclerosis
    Brain Stem Infarctions
    Locked-in Syndrome
    Muscular Dystrophies

NCT06094205

Leigh R. Hochberg, MD, PhD.

26 January 2024

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