Mind-controlled devices: tiny brain chip tested in paralysis patients

NCT ID NCT03161067

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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 Results may not be published yet.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

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Status unknown
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First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early study tests a brain implant system called BiCNS in 5 people with tetraplegia (paralysis from the neck down). The implant records brain signals and may allow users to control assistive devices like a robotic arm. The main goal is safety—making sure the device stays in place without causing harm over 52 weeks.

What this could mean

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

Active substance
NeuroPort brain implant system
What this could lead to
If it works, this could help people with paralysis control assistive devices like robotic arms using only their thoughts.
What could go wrong
This is a very early feasibility study with only 5 participants. The implant may cause infection or need removal, and success is not guaranteed.

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 5 people

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

Started

Aug 2017

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 65 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: Participants must meet all inclusion criteria, verified by medical evaluation, psychological evaluation, and review of medical history. Inclusion criteria include: * Participants with C4-C6 tetraplegia from any etiology except neurodegenerative disease (e.g. amyotrophic lateral sclerosis) or active cancer. * Complete or incomplete spinal cord injury classified by the American Spinal Injury Association (ASIA) as A or B or C if fewer than three muscle groups in the leg and foot (as identified in the ASIA Impairment Scale) can be contracted * Injury more than one year prior to enrollment * Participant has a life expectancy of greater than 5 years * Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants * 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 to up to fifty 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 * Pain well controlled without narcotic medications * No other neurological, orthopedic conditions beyond the spinal cord injury * Participant consents to the study and still wishes to participate at the time of the study Exclusion Criteria: All interested participants will be reviewed for the presence of exclusion criteria by medical evaluation, review of medical history, self (or assistant) report and evaluation by a psychologist. Presence of any of the following criteria will exclude participants from eligibility to participate. In addition, the medical team has the right to withdraw the participant at any time if any of the exclusion criteria emerge and participants can withdraw at any time for any reason. Withdrawal details are outlined below exclusion criteria. Exclusion criteria include: * Neurological conditions: Impaired receptive and/or expressive verbal communication skills * Presence of memory impairment on the Rey Auditory Verbal Learning Test * Intellectual impairment: score of 26 or less on the Mini-Mental State Examination or history of Intelligence Quotient \< 80 * Chronic psychiatric illness, including psychosis and treatment-resistant major depression, as indicated by a diagnosis of Axis I or Axis II on the Symptom Checklist-90-Revised Test * Ventilator dependent * Implanted devices such as: pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, cochlear implants or any other implantable device incompatible with MRI. * History of drug or alcohol dependence in past 24 months * Cerebral lesions affecting frontal and parietal lobes * 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 make control unsuitable (such as tremor or spasticity) * 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, 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 no worse than 20/30 * 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 * An implanted ventricular shunt * Suicidal ideation within the past 12 months * Medications that affect neuroplasticity: neuroleptics, Benzodiazepines (BDZ), Tricyclic Antidepressants (TCA).

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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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Department of Neurology

    RECRUITING

    Baltimore, Maryland, 21287, United States

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