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Brain-Machine Interface

Brain-Computer Interface Device for Severe Neurological Disorders (BRAVO Trial)

N/A

Recruiting

Led By Karunesh Ganguly, MD, PhD

Research Sponsored by Karunesh Ganguly

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living

Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years post-implant period

Awards & highlights

BRAVO Trial Summary

This trial will test whether electrical signals from the brain can be used to control devices for motor and speech control in adults with severe neurological disorders.

Who is the study for?

Adults over 21 with severe limitations in upper limb use due to conditions like stroke, ALS, MS, or spinal cord injury. They must have significant disability and be at least one year post-symptom onset for strokes or injuries. Participants need to live within two hours of UCSF and cannot be pregnant, have certain mental health issues, substance abuse history, major organ failure, prior brain surgery or seizures.Check my eligibility

What is being tested?

The trial is testing a device combining PMT/Blackrock technology that uses brain signals (ECoG) for controlling motor and speech devices in those severely affected by neurological disorders.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from wearing the device, skin irritation from electrodes contact points and possible risks associated with invasive monitoring of brain activity.

BRAVO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need help with daily activities due to my disability.

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I have limited use of my arms due to a neurological condition.

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I am older than 21 years.

BRAVO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years post-implant period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years post-implant period

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years post-implant period for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

NIDCD Primary Objective 1

NIDCD Primary Objective 2

Secondary outcome measures

NIDCD Secondary Objective 1

NIDCD Secondary Objective 2

BRAVO Trial Design

1Treatment groups

Experimental Treatment

Group I: Electrocorticography-based brain computer interfaceExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Karunesh GangulyLead Sponsor

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

330 Previous Clinical Trials

178,468 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,552 Total Patients Enrolled

Media Library

PMT/Blackrock Combination Device (Brain-Machine Interface) Clinical Trial Eligibility Overview. Trial Name: NCT03698149 — N/A

Spinal Cord Injury Research Study Groups: Electrocorticography-based brain computer interface

Spinal Cord Injury Clinical Trial 2023: PMT/Blackrock Combination Device Highlights & Side Effects. Trial Name: NCT03698149 — N/A

PMT/Blackrock Combination Device (Brain-Machine Interface) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03698149 — N/A

Frequently Asked Questions

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

Is this experiment still open to participation?

"Affirmative. The clinicaltrials.gov records indicate that the enrollment of subjects for this research is currently ongoing, with a first post date of November 9th 2018 and last update on July 29th 2022. 3 patients are sought from one medical centre."

Answered by AI

What is the present capacity for enrollment into this experiment?

"Indeed, the data hosted on clinicaltrials.gov states that this medical experiment is presently recruiting; first posted November 9th 2018 and most recently updated July 29th 2022 with a need of 3 participants across one site."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria

Moses, David A., Sean L. Metzger, Jessie R. Liu, Gopala K. Anumanchipalli, Joseph G. Makin, Pengfei F. Sun, Josh Chartier, et al.. 2021. “Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2027540.

clinicaltrials.govStudy

ECoG BMI for Motor and Speech Control

Karunesh Ganguly 2018. "ECoG BMI for Motor and Speech Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03698149.

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