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Neural Interface

BrainGate2 System for Speech Impairment (BG-Speech-02 Trial)

N/A
Recruiting
Led By Sergey Stavisky, Ph.D.
Research Sponsored by Leigh R. Hochberg, MD, PhD.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complete or incomplete tetraplegia (quadriplegia)
Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
Must not have
A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening
Between 18 and 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at participant exit from study, or up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to develop tech to help people with speech difficulties communicate via computer, just by trying to speak.

Who is the study for?
This trial is for people with severe paralysis (tetraplegia) due to conditions like spinal cord injury or ALS, who live close to the study site and have stable health. They should be between 18-80 years old, at least a year post-injury, and able to communicate in some way.
What is being tested?
The BrainGate2 Neural Interface System is being tested. It's a device that could help people with speech impairments caused by paralysis communicate through a computer by attempting to speak.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort at the implant site, infection risk from surgery, and possible unknown risks associated with brain-computer interfaces.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have paralysis affecting all four limbs.
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I have a diagnosed condition affecting my nerves or muscles, such as ALS or muscular dystrophy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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It's been over a year since my injury, and my recovery has been stable for the last 3 months.
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I am between 18 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at participant exit from study, or up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at participant exit from study, or up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
Secondary study objectives
Decoded speech output accuracy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BrainGate Neural Interface SystemExperimental Treatment1 Intervention
Placement of the BrainGate2 sensor(s) into the speech-related cortex

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
353 Previous Clinical Trials
181,475 Total Patients Enrolled
Leigh R. Hochberg, MD, PhD.Lead Sponsor
3 Previous Clinical Trials
19 Total Patients Enrolled
Sergey Stavisky, Ph.D.Principal InvestigatorUniversity of California, Davis
~1 spots leftby Aug 2027
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