Investigation of a brain-computer interface system for communication in patients with severe disabilities
Official title: Investigation on the Cortical Communication (CortiCom) System
Run by Johns Hopkins University · NCT03567213 · Data updated 2026-11-12
This study is testing a new brain-computer interface that helps people with severe disabilities, like tetraplegia and ALS, communicate better by using signals from their brain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years to 70 Years |
| Sex | All |
| Enrollment | 3 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | December 14, 2021 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | August 21, 2026 |
| Trial ID | NCT03567213 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 22-70 with a clinical diagnosis of tetraplegia, locked-in syndrome, brainstem stroke, or ALS, who have experienced their condition for at least one year.
✕Probably not a fit
Patients with conditions not related to severe motor impairments or those who do not meet the surgical safety criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the Cortical Communication (CortiCom) system, which involves the surgical implantation of electrode grids in the brain to capture neural signals related to speech and movement. Participants will have up to two grids implanted for six months, allowing researchers to assess the effectiveness of using neural signals from both the speech and motor cortex for controlling devices. The goal is to determine which neural control strategy provides the most intuitive and efficient means of communication for individuals with conditions like tetraplegia and ALS.
Why it matters
Potential benefit: If successful, this study could significantly enhance communication abilities for patients with severe motor impairments.
How similar studies have gone: Other studies have shown promise in using brain-computer interfaces for communication, but this specific approach of simultaneously recording from speech and motor regions is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS) * Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment * 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. * 22-70 years * Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants * Ability to communicate reliably, such as through eye movement * Willingness and ability to provide informed consent * Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study * Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study * Ability to understand and comply with study session instructions * Participant consents to the study and still wishes to participate at the time of the study Exclusion Criteria: * Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities. * Suicide attempt or persistent suicidal ideation within the past 12 months. * Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants. * History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months * Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation) * Other chronic, unstable medical conditions that could interfere with subject participation. * Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team) * Prior cranioplasty * Inability to undergo MRI or anticipated need for an MRI during the study period * Participants with active infections or unexplained fever * Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe * Pregnancy (confirmation through blood test) * Nursing an infant, planning to become pregnant, or not using adequate birth control * Corrected vision poorer than 20/100 * HIV or AIDS infection * Existing scalp lesions or skin breakdown * Chronic oral or intravenous use of steroids or immunosuppressive therapy * Active cancer within the past year or requires chemotherapy * Uncontrolled autonomic dysreflexia within the past 3 months * Hydrocephalus with or without an implanted ventricular shunt * Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery
Where it's running
-
Johns Hopkins Medicine
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Nathan E Crone, MD — Professor of Neurology
- Study coordinator: Nathan E Crone, MD
- Email: ncrone@jhmi.edu
- Phone: 410-955-6772
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using a brain-computer interface to help people with speech difficulties communicate
This study is testing a brain-computer interface to help people who can't speak due to conditions like ALS communicate by turning their thoughts into speech.
-
Using a neural interface to help people with tetraplegia control devices with their thoughts
This study is testing a new brain interface that helps people with tetraplegia, especially those with ALS, control devices like computers just by thinking about it.
-
Feasibility of a brain-computer interface for people with tetraplegia
This study is testing a new brain-computer interface that helps people with tetraplegia control a computer and other devices just by thinking, to see if it’s safe and effective.
-
Wireless brain implant for controlling devices
This study is testing a new wireless brain implant that helps paralyzed and amputee patients control devices just by thinking, to see if it can improve their daily lives.
-
Using a brain-computer interface to help people with tetraplegia communicate
This study is testing a new brain-computer interface to help people with tetraplegia communicate more easily using a tablet.
-
Communication through a brain implant for people with locked-in syndrome
This study is testing a brain implant that helps people with locked-in syndrome communicate by translating their brain activity into messages.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.