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Neural Interface System

BrainGate2 System for Quadriplegia (BG-Speech-01 Trial)

N/A
Recruiting
Led By Jaimie Henderson, MD
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
Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at participant exit from study, or up to 5 years
Awards & highlights

BG-Speech-01 Trial Summary

This trial aims to show that people with tetraplegia can use their thoughts to control a computer and other devices, increasing independence.

Who is the study for?
This trial is for adults aged 18-80 with tetraplegia due to conditions like ALS, spinal cord injury, or stroke. They must be unable to speak clearly or at all but have one reliable way to communicate. Participants should live within a three-hour drive of the study site and are expected to survive more than six months.Check my eligibility
What is being tested?
The BrainGate2 Neural Interface System is being tested for its safety and ability to let people with severe paralysis control a computer cursor and other devices using their thoughts alone.See study design
What are the potential side effects?
As this trial tests a neural interface system, potential side effects may include discomfort at the implantation site, headache, infection risk from surgery, and possible device-related complications.

BG-Speech-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have ALS and cannot speak or have severe speech difficulties that have worsened recently.
Select...
I have been diagnosed with ALS by a neurology specialist.

BG-Speech-01 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device Safety
Secondary outcome measures
Device Feasibility

BG-Speech-01 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
330 Previous Clinical Trials
178,469 Total Patients Enrolled
Leigh R. Hochberg, MD, PhD.Lead Sponsor
2 Previous Clinical Trials
17 Total Patients Enrolled
Jaimie Henderson, MDPrincipal InvestigatorStanford University

Media Library

BrainGate Neural Interface System (Neural Interface System) Clinical Trial Eligibility Overview. Trial Name: NCT05724173 — N/A
Spinal Cord Injury Research Study Groups: BrainGate Neural Interface System
Spinal Cord Injury Clinical Trial 2023: BrainGate Neural Interface System Highlights & Side Effects. Trial Name: NCT05724173 — N/A
BrainGate Neural Interface System (Neural Interface System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724173 — N/A

Frequently Asked Questions

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

For whom is enrollment open for this clinical trial?

"This clinical trial is seeking two human volunteers aged between 18 and 75 with a definitive diagnosis of locked-in syndrome. Additionally, candidates must have been diagnosed with amyotrophic lateral sclerosis (ALS) accompanied by anarthria or pronounced dysarthria that has worsened in the previous four months."

Answered by AI

Is the enrollment period for this clinical trial still active?

"Affirmative. Clinicaltrials.gov verifies that the trial, which debuted on March 21st 2023, is still enrolling participants. An estimated 2 people need to be sourced from two sites for this research study."

Answered by AI

To what extent is the recruitment pool expanding for this research project?

"Confirmed. According to clinicaltrials.gov, this trial that was launched on the 21st of March 2023 is still recruiting participants from two locations with a total goal of 2 enrolments."

Answered by AI

Is the enrollment for this trial restricted by age, and if so, at what threshold?

"The minimum age for enrolment in this clinical trial is 18 and the maximum age limit is 75, as outlined in the eligibility criteria."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
Leigh R. Hochberg, MD, PhD. 2023. "Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724173.
All > Lou Gehrigs Disease > Muscular Dystrophy
~1 spots leftby Jul 2026
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