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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

CortiCom Trial 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.Check my eligibility
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.See study design
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.

CortiCom Trial 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.
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.

CortiCom Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to device explantation
Secondary outcome measures
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.

CortiCom 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
1,337 Previous Clinical Trials
648,841 Total Patients Enrolled
40 Trials studying Amyotrophic Lateral Sclerosis
18,298 Patients Enrolled for Amyotrophic Lateral Sclerosis
Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,767 Total Patients Enrolled
10 Trials studying Amyotrophic Lateral Sclerosis
1,869 Patients Enrolled for Amyotrophic Lateral Sclerosis
Nathan E Crone, MDPrincipal InvestigatorProfessor of Neurology

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

Frequently Asked Questions

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

What is the total enrollment of participants for this experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is actively searching for volunteers, first posted on December 14th 2021 and last updated February 15th 2022. The study aims to recruit 3 participants from a single medical centre."

Answered by AI

Does this clinical trial have an age restriction, and are individuals below 55 years of age admissible?

"Applicants aged between 22 and 70 are eligible for this trial, but there are additional studies available to those less than 18 years old (8) or senior citizens over 65 (163)."

Answered by AI

Do I qualify to join this medical examination?

"The requirements for enrolment into this trial are patients between 22 and 70 years of age, who have been diagnosed with Weber Syndrome. The total number of participants sought is 3."

Answered by AI

Who else is applying?

What state do they live in?
British Columbia
Colorado
Other
Maryland
What site did they apply to?
Johns Hopkins Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

I have Adhesive Arachnoiditis. I want more control of my life. Had a stroke last October and can’t walk without use of a walker or Rollator.
PatientReceived no prior treatments
I have constant neck and mid back pain from scoliosis and now lower back pain.
PatientReceived 1 prior treatment
I have tried over 3 different medications and hope this research can help benefit me.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What exactly is the trial? What type of study? Modalities? Drugs? How far will i need to go and how long do these visits take?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Johns Hopkins Medicine: < 24 hours
Average response time
  • < 2 Days
~1 spots leftby Aug 2025