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Neurostimulation Device

Implantation of brain-computer interface for communication in ALS, quadriplegia, and Locked In Syndrome (CortiCom Trial)

Verified Trial
N/A
Recruiting
Led By Nathan E Crone, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS.
Have you been diagnosed with a stroke or other injury affecting the brainstem?
Timeline
Screening 60 days
Treatment 6 months
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a brain-computer interface that consists of platinum grids being implanted in the brain to pick up neural signals. Up to 128 channels will be used to test this interface for six months.

Who is the study for?
This trial is for adults aged 22-70 with conditions like Locked-In Syndrome, ALS, or tetraplegia due to brainstem stroke or injury. Participants must have had their condition for at least a year and be able to communicate through eye movement. People with active infections, epilepsy, substance abuse history, MRI incompatibility, certain medical conditions or surgeries that affect implant safety are excluded.
What is being tested?
The CortiCom system involves surgically placing up to two electrode grids on the brain's surface over areas controlling speech and arm movements. This device aims to help people with severe paralysis communicate better by translating brain signals into speech or text.
What are the potential side effects?
Potential side effects aren't specified but may include risks associated with surgical implantation such as infection, bleeding, and reactions specific to having a foreign body within the skull like inflammation or skin breakdown around the implanted pedestal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe paralysis or muscle weakness in all four limbs, possibly with major speech difficulties.
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I have had a stroke or injury that affected my brainstem.
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I have tetraplegia or quadriplegia due to a spinal cord injury.
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I have a condition that affects my speech and makes my arms or legs weak.
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I have been diagnosed with ALS or motor neuron disease.

Timeline

Screening ~ 60 days
Treatment ~ 6 months
Follow Up ~90 days
This trial's timeline: 60 days for screening, 6 months for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to device explantation
Secondary study objectives
Speed of brain-computer interface control, i.e. time to complete successful trials (in seconds).
Success rate in controlling the brain computer interface, i.e. ratio of successful trials to total trials.

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: Surgical implantation of the CortiCom systemExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,378 Previous Clinical Trials
652,189 Total Patients Enrolled
45 Trials studying Amyotrophic Lateral Sclerosis
21,011 Patients Enrolled for Amyotrophic Lateral Sclerosis
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,807 Total Patients Enrolled
12 Trials studying Amyotrophic Lateral Sclerosis
1,913 Patients Enrolled for Amyotrophic Lateral Sclerosis
Nathan E Crone, MDPrincipal InvestigatorProfessor of Neurology
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

CortiCom System (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT03567213 — N/A
Amyotrophic Lateral Sclerosis Research Study Groups: Surgical implantation of the CortiCom system
Amyotrophic Lateral Sclerosis Clinical Trial 2023: CortiCom System Highlights & Side Effects. Trial Name: NCT03567213 — N/A
CortiCom System (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03567213 — N/A
Amyotrophic Lateral Sclerosis Patient Testimony for trial: Trial Name: NCT03567213 — N/A
~1 spots leftby Aug 2025
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