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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.
Must not have
Complete or incomplete tetraplegia (quadriplegia)
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 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have paralysis that affects all four of my limbs.
Select...
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
Device Safety
Secondary study objectives
Device Feasibility

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
361 Previous Clinical Trials
182,295 Total Patients Enrolled
3 Trials studying Quadriplegia
31 Patients Enrolled for Quadriplegia
Leigh R. Hochberg, MD, PhD.Lead Sponsor
3 Previous Clinical Trials
31 Total Patients Enrolled
3 Trials studying Quadriplegia
31 Patients Enrolled for Quadriplegia
Jaimie Henderson, MDPrincipal InvestigatorStanford University

Media Library

BrainGate Neural Interface System (Neural Interface System) Clinical Trial Eligibility Overview. Trial Name: NCT05724173 — N/A
Quadriplegia Research Study Groups: BrainGate Neural Interface System
Quadriplegia 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
~1 spots leftby Jul 2026
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