What side effects are associated with this type of intervention?

Common treatments for spinal cord injury (SCI) that involve neuromodulation and neurostimulation, such as transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS), have specific side effects. TMS can cause mild headaches, scalp discomfort, and in rare cases, seizures. VNS may lead to voice changes, throat pain, and coughing. Both treatments are generally well-tolerated, with serious adverse events being rare.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments that directly utilize Electrocorticography (ECoG) for spinal cord injury (SCI). However, the FDA has approved various drugs and therapies aimed at managing symptoms and complications of SCI. These include corticosteroids like methylprednisolone for reducing inflammation, and other medications for managing pain, spasticity, and secondary complications. Research is ongoing in the field of neuroprosthetics and brain-machine interfaces, which includes ECoG, to develop advanced treatments for SCI.

What other types of research exist?

Promising, novel alternatives to Electrocorticography (ECoG) for spinal cord injury patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown potential in motor recovery and neurorehabilitation. 2) Non-invasive Brain-Computer Interfaces (BCIs) that utilize electroencephalography (EEG) to record brain activity and translate it into control signals for external devices. 3) Functional Electrical Stimulation (FES), which involves electrical stimulation of muscles to restore motor functions. These technologies are advancing rapidly and hold promise for improving the quality of life for spinal cord injury patients.

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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

Must not have

History of seizures

Immunocompromised

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years post-implant period

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a method that uses sensors on the brain to help people with severe neurological disorders control devices and speak. The sensors pick up brain signals and translate them into actions or speech. This could help those who struggle with movement and communication due to their condition.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures.

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My immune system is weak.

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I have had brain surgery before.

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I am unable to understand and give consent for treatment.

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I currently have an infection.

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I need special treatments like ECT or TMS for a long-term condition.

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I have other serious health issues like uncontrolled blood pressure or organ failure.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

NIDCD Primary Objective 1

NIDCD Primary Objective 2

Secondary study objectives

NIDCD Secondary Objective 1

NIDCD Secondary Objective 2

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: Electrocorticography-based brain computer interfaceExperimental Treatment1 Intervention

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for spinal cord injury (SCI) often involve neuromodulation and neurorehabilitation therapies, such as epidural electrical stimulation and Electrocorticography (ECoG). These treatments work by facilitating spinal circuitry and activating multisegmental coordination, which helps restore motor functions. Electrical stimulation at different spinal levels re-establishes disrupted communication pathways, offering potential improvements in motor abilities and quality of life for SCI patients.

Combined Supra- and Sub-Lesional Epidural Electrical Stimulation for Restoration of the Motor Functions after Spinal Cord Injury in Mini Pigs.