Motor Recovery Through Plasticity-Inducing Cortical Stimulation for Ischemic Stroke

This study is looking at a new way to help people recover movement in their arms after an ischemic stroke. It uses a device called the CorTec Brain Interchange (BIC) System, which is surgically placed in the brain. The goal is to use special stimulation to encourage the brain to heal and improve arm function. Researchers will be watching to see how much arm movement improves over two years. You might be able to join if you are 22-75 years old, had an ischemic stroke at least six months ago, and have arm weakness that needs surgical help. You also need to be able to participate in rehabilitation and have a certain level of disability.

Study design: This is an open, prospective feasibility study planning to enroll 4 participants. It is not specified if it is randomized or blinded.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for two years to measure upper limb impairment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Motor Recovery Through Plasticity-Inducing Cortical Stimulation

Recruiting

NAAges 22–75InterventionalTreatment

University of Washington

~4 participants

Updated 2026-04-13 on ClinicalTrials.gov

What's tested:CorTec Brain Interchange (BIC) System

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Measuring upper limb impairment in stroke rehabilitation

Measured over Two years

Conditions

Stroke, Ischemic

Where it's being run

1 sites across 1 states

Washington1

Study leadership

Jeffrey Ojemann · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Amy Anderson

[email protected]

206-744-9364

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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

What this trial measures

Measuring upper limb impairment in stroke rehabilitationTwo years
The primary outcome measure in the study focus on measuring upper limb impairment to ensure that the use of the CorTec Brain Interchange system is not detrimental for use in studying stimulation paradigms to improve stroke rehabilitation. Limb impairment will be assessed for all patients weekly during the rehabilitation period and at all monthly post-rehab monitoring visits using the primary behavioral measures of the study, UEFM (Upper Extremity Fuegl-Myer) arm motor score and the WMFT (Wolf Motor Function Test), which will track individual trends of motor improvement and motor function, respectively. In four subjects the degree of potentially confounding variables (such as injury and/or patient variability) will likely inhibit extrapolation of therapeutic outcomes to the stroke population at large.

Trialytics