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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 belowSelect...
I have severe paralysis or muscle weakness in all four limbs, possibly with major speech difficulties.
Select...
I have had a stroke or injury that affected my brainstem.
Select...
I have tetraplegia or quadriplegia due to a spinal cord injury.
Select...
I have a condition that affects my speech and makes my arms or legs weak.
Select...
I have been diagnosed with ALS or motor neuron disease.
Timeline
Screening ~ 60 days4 visits
Treatment ~ 6 months68 visits
Follow Up ~ 90 days12 visits
Screening ~ 60 days
Treatment ~ 6 months
Follow Up ~90 days
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
1,385 Previous Clinical Trials
652,685 Total Patients Enrolled
46 Trials studying Amyotrophic Lateral Sclerosis
21,023 Patients Enrolled for Amyotrophic Lateral Sclerosis
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,670 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Epilepsy.I have a condition that affects my speech and makes my arms or legs weak.I have been diagnosed with ALS or motor neuron disease.I have tetraplegia or quadriplegia due to a spinal cord injury.You have either tried to commit suicide or thought about it often within the past year.I can communicate effectively using my eyes.I am not on long-term steroids or drugs that weaken my immune system.You cannot have an MRI or will need an MRI during the study period.I have been diagnosed with epileptic seizures.I have been diagnosed with tetraplegia, brainstem stroke, ALS, or Locked-in Syndrome.You have other medical conditions that are not under control and may affect your ability to participate in the study.You have struggled with drug or alcohol addiction within the past two years.My brain scans show it's too risky to place an implant where needed.I have severe paralysis or muscle weakness in all four limbs, possibly with major speech difficulties.I do not have conditions like severe diabetes, hepatitis, autoimmune diseases, epilepsy, skin issues, or blood disorders that make surgery risky.I have sores or broken skin on my scalp.I currently have an active infection or unexplained fever.I have hydrocephalus, with or without a shunt.I have had a stroke or injury that affected my brainstem.I am between 22 and 70 years old.My diagnosis of tetraplegia, ALS, stroke, or LIS happened over a year ago.I have had surgery to repair my skull.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical implantation of the CortiCom system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 60 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 90 Months after you stop receiving the treatment.
Amyotrophic Lateral Sclerosis Patient Testimony for trial: Trial Name: NCT03567213 — N/A