Mind-Reading implant aims to give a voice to the paralyzed

NCT ID NCT03567213

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests a brain-computer interface called CortiCom, which is surgically placed on the brain's surface to record signals related to speech and arm movement. The goal is to see if these signals can be decoded to control software and devices, potentially helping people with paralysis communicate. The study involves up to three participants with conditions like tetraplegia or locked-in syndrome, and the device is implanted for about six months to assess safety and feasibility.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Surgical implantation of the CortiCom system, a brain-computer interface with electrode grids placed on the brain's surface to record signals related to speech and movement.
What this could lead to
If successful, this could pave the way for a brain-computer interface that helps people with severe paralysis communicate and interact with the world using their thoughts.
What could go wrong
This is a very early, small study (only 3 participants) focused on safety and feasibility. The device is only implanted for six months, and there are risks like infection or the device needing to be removed early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Johns Hopkins Medicine

    RECRUITING

    Baltimore, Maryland, 21205, United States

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