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Brain chip aims to rewire movement after stroke

NCT ID NCT06506279

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a surgically implanted device called the CorTec Brain Interchange (BIC) System in 4 people who had an ischemic stroke at least 6 months ago and have lasting arm weakness. The device delivers electrical stimulation designed to encourage the brain to rewire itself and improve arm function. Participants will undergo weekly assessments during rehabilitation and monthly follow-ups. Because this is a very small, early feasibility study, the main goal is to ensure the device is safe to use in future, larger trials.

What this could mean

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

Active substance
CorTec Brain Interchange (BIC) System (implanted device)
What this could lead to
If it works, this could point toward a new way to help stroke survivors regain arm movement.
What could go wrong
This is a very early feasibility study with only 4 people. It is designed mainly to check safety, not to prove effectiveness. Individual differences may make results hard to generalize.

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 4 people

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

Started

Jul 2025

Expected to finish

Jun 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 75 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: 22-75 years of age * History of ischemic stroke * Minimum 6 months post-ischemic cortical stroke * Levels of hemiparesis that warrant surgical intervention (upper limb impairment) * Able to participate in a meaningful way in rehabilitation (defined by upper extremity Fugl-Myer (UEFM) score of 25-45 * Disability measured between 3 and 4 on the modified Rankin Scale * Minimum of 30% preservation of the corticospinal pathways in MRI imaging * Observable motor output of the upper limb in response to TMS delivered to the motor cortex * Available for the duration of the study, 54 weeks for multiple visits (38 weeks implanted and 16 weeks post-explant follow-up). * All inclusion and exclusion criteria will be assessed within 90 days before the device implantation procedure (though the PI may determine to override the 90-day limit for MRI imaging results review). Exclusion Criteria: * Unable to discontinue anti-platelet medication for 7 days pre- and 3 days post-op * On therapeutic anticoagulation * A history of unprovoked deep vein thrombosis or any pulmonary embolus * The presence of a bleeding disorder which significantly increases the chances that the patient will have a hemorrhagic complication in relation to study procedures. * Other medical history indicating increased risk of thrombosis per investigator discretion * Any history of seizures * Pregnancy * Geriatric Depression Score greater than 10 * Montreal Cognitive Assessment below 22 unless attributable to aphasia and approved by PI * Columbia Suicide Scale ideation score above 1 * Aphasia or cognitive deficits substantial enough to prevent: * communication of pain and discomfort due to study procedures * understanding of motor testing or rehabilitation tasks * Severe Neglect as measured by NIH Stroke Scale Question 11 score of 2, which represents a "Profound hemi-inattention or extinction to more than one modality; does not recognize own hand or orients to only one side of space." * Cardiac morbidity that in the judgment of the investigators would represent an increased safety risk * History of spontaneous hemorrhagic stroke * Major, active neurological, psychiatric, or medical comorbidity that would likely interfere with study procedures * Any active infection requiring antimicrobial therapy * Inability to participate with proposed rehabilitation strategies * Presence of any other implanted devices (cochlear implants, pacemakers, etc.). * During this study no occupational, physical, or speech therapy is permitted apart from that provided by the study protocol. Patients who require therapy beyond what is delivered in this study will not be enrolled * All inclusion and exclusion criteria will be assessed within 90 days before the device implantation procedure (though the PI may determine to override the 90-day limit for MRI imaging results review). If a patient has glenohumeral subluxation, adhesive capsulitis, or contractures of the upper extremities, they must undergo additional screening for pain with range-of-motion and be approved by the enrolling clinician. If a patient requires any medication not already explicitly excluded as part of defined safety criteria, the clinical staff affiliated with this study will determine if the patient should be excluded at their own discretion to ensure the integrity of this study. \-

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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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Washington

    RECRUITING

    Seattle, Washington, 98104, United States

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