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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at participant exit from study, or up to 5 years

Awards & highlights

BG-Speech-02 Trial 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.Check my eligibility

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.See study design

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.

BG-Speech-02 Trial 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.

BG-Speech-02 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at participant exit from study, or up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant

Secondary outcome measures

Decoded speech output accuracy

BG-Speech-02 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

330 Previous Clinical Trials

178,469 Total Patients Enrolled

Leigh R. Hochberg, MD, PhD.Lead Sponsor

2 Previous Clinical Trials

17 Total Patients Enrolled

Sergey Stavisky, Ph.D.Principal InvestigatorUniversity of California, Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment include elderly individuals aged seventy and above?

"This clinical trial seeks to enroll patients who are older than 18 and under the age of 80."

Answered by AI

What is the eligibility criteria for participation in this research project?

"In order to qualify for participation in this trial, individuals must be diagnosed with muscular dystrophy and fall within the age range of 18-80. The research team is currently seeking two volunteers for its study."

Answered by AI

Is enrollment in this research project still open?

"Affirmative. According to clinicaltrials.gov, this study is actively searching for volunteers with the first post being on October 1st 2024 and most recently edited on October 16th 2023. The research endeavour requires 2 people from a single centre."

Answered by AI

What is the size of the cohort that has been recruited for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this trial which first opened for recruitment on October 1st 2024 is currently seeking applicants. A total of 2 participants must be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Leigh R. Hochberg, MD, PhD. 2024. "Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06094205.

All > Lou Gehrigs Disease > Muscular Dystrophy