CorTec Brain Interchange for Stroke

(MRPICS Trial)

Overseen By Amy Anderson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Seizures, Pregnancy, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

4 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with upper limb problems following a stroke. The treatment uses the CorTec Brain Interchange (BIC) System to stimulate brain plasticity, the brain's ability to adapt and change, with the aim of improving arm and hand movement. It is suitable for those who experienced an ischemic stroke at least six months ago and still face significant difficulties using their arm. Participants should be prepared for a year-long commitment to the study, which includes surgery and follow-up visits. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance recovery options for stroke survivors.

Will I have to stop taking my current medications?

The trial requires participants to stop taking anti-platelet medication for 7 days before and 3 days after the surgery. If you are on therapeutic anticoagulation or need other medications not mentioned, the clinical staff will decide if you can participate.

What prior data suggests that the CorTec Brain Interchange (BIC) System is safe for stroke rehabilitation?

Research shows that the CorTec Brain Interchange (BIC) System is undergoing clinical trials to assess its safety and effectiveness in aiding stroke recovery. Initial studies focus on gathering safety data and evaluating whether electrical stimulation can enhance arm movement.

The system has been implanted in stroke recovery patients participating in these trials to collect early safety information. Although the full safety profile is still under investigation, these early tests are crucial for assessing patient tolerance to the system.

At this early testing stage, the primary goal is to ensure the treatment's safety and absence of major side effects. The regulated trial setting underscores the priority of safety. For those considering trial participation, this indicates that researchers are closely monitoring the treatment for any adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CorTec Brain Interchange (BIC) System is unique because it aims to enhance motor recovery in stroke patients through plasticity-inducing cortical stimulation. Unlike traditional rehabilitation methods, which often rely on physical therapy to improve motor function, the BIC System directly stimulates the brain's cortex to promote neural plasticity and recovery. Researchers are excited about this approach because it targets the brain's natural ability to rewire itself, potentially leading to faster and more effective recovery outcomes for patients with upper extremity deficits following a stroke.

What evidence suggests that the CorTec Brain Interchange System is effective for stroke rehabilitation?

Studies have shown that the CorTec Brain Interchange (BIC) System can improve movement recovery after a stroke. This system uses gentle electrical signals to encourage the brain to adapt and form new connections. Research indicates that this method enhances the benefits of regular therapy, aiding stroke survivors in regaining movement in their arms and hands. Early findings suggest that this treatment, which participants in this trial will receive, could be a promising option for those with arm and hand difficulties after a stroke. Initial studies also highlight its potential to significantly improve recovery by targeting specific brain areas involved in movement. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeffrey Ojemann

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 22-75 with moderate upper limb impairment, who can engage in rehab and have had an ischemic cortical stroke at least 6 months ago. They must be able to visit the clinic for 54 weeks and show some motor response in their affected limb when tested.

Inclusion Criteria

I am between 22 and 75 years old.

It has been at least 6 months since my stroke.

I have had a stroke caused by a blood clot.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive plasticity-inducing cortical stimulation therapy using the CorTec Brain Interchange system

12 months

Weekly visits for rehabilitation

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Monthly post-rehab monitoring visits

What Are the Treatments Tested in This Trial?

Interventions

• CorTec Brain Interchange (BIC) System

Trial Overview The study tests the CorTec Brain Interchange System's ability to enhance arm function recovery after a stroke by using special brain stimulation techniques that encourage neuroplasticity, based on promising earlier research.

How Is the Trial Designed?

Group I: Motor Recovery through Plasticity-Inducing Cortical Stimulation Experimental Treatment 1 Intervention

Single arm study of post-ischemic stroke patients with an upper extremity deficit.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Vertebrobasilar insufficiency is a significant but often underestimated condition in cerebrovascular disease, which can be classified into simple and complex types, and is frequently associated with issues in multiple extracranial vessels.

There is a growing recognition of the need for direct surgical interventions on the vertebral artery, such as vertebral artery to common carotid artery transposition, which could improve outcomes for patients with cerebrovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extracranial surgical procedures in the management of vertebrobasilar insufficiency. Story, JL., Brown, WE., Abou-Samra, M., et al.[2019]

A 47-year-old female patient with diffuse axonal injury (DAI) showed significant recovery of motor function over 24 months, correlating with changes observed in diffusion tensor imaging (DTI).

At 24 months, the patient's fractional anisotropy (FA) in the brainstem increased significantly compared to initial measurements, indicating recovery of the corticospinal tract, which is crucial for motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of corticospinal tract with diffuse axonal injury: a diffusion tensor image study. Han, BS., Kim, SH., Kim, OL., et al.[2007]

In a study of 27 patients with basilar bifurcation aneurysms treated between 2013 and 2018, microsurgical clipping resulted in a good outcome (GOS score of 4-5) for 77.8% of living patients at 6 months post-surgery.

The trans-frontotemporal approach was found to be the most effective surgical method for treating upper basilar bifurcation aneurysms, particularly in cases complicated by subarachnoid hemorrhage and brain swelling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microsurgical Clipping of Complex Basilar Bifurcation Aneurysms through Different Approachs: Surgical Techniques and Results. Wang, H., Sun, Y., Fan, Y., et al.[2023]

Using the ROSA One(R) Robot Assistance Platform in non-human primates allowed for highly accurate targeting and stimulation of the corticospinal tract, improving the precision of accessing subcortical structures compared to traditional methods.

This innovative approach enables simultaneous implantation of multiple deep brain stimulation probes, which could enhance our understanding of the corticospinal tract's role in motor functions and its interactions with spinal cord circuits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot Assisted Neurosurgery for High-Accuracy, Minimally-Invasive Deep Brain Electrophysiology in Monkeys. Ho, JC., Liang, L., Grigsby, EM., et al.[2022]

In a study involving 7 patients with brain tumors, neuronavigation using intraoperative diffusion-weighted imaging (iDWI) combined with subcortical stimulation successfully identified the pyramidal tract, helping to avoid surgical injury.

The method showed high accuracy, with an average error of only 0.79 mm in locating the pyramidal tract, and positive motor responses were detected in 5 out of 7 patients when the stimulation site was within 4.7 mm of the depicted bundle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of the pyramidal tract by neuronavigation based on intraoperative diffusion-weighted imaging combined with subcortical stimulation. Ozawa, N., Muragaki, Y., Nakamura, R., et al.[2009]

Citations

1. withpower.com withpower.com/trial/phase-ischemic-stroke-2025-bffad

CorTec Brain Interchange for Stroke (MRPICS Trial) This trial is for stroke survivors aged 22-75 with moderate upper limb impairment, who can engage in rehab and have had an ischemic cortical stroke at least 6 ...

2. cortec-neuro.com cortec-neuro.com/story/the-brain-interchange-system-for-stroke-rehabilitation/

The Brain Interchange System for Stroke Rehabilitation | CorTec Fundamental studies already demonstrated the effectiveness of this mechanism successfully. The therapeutic success of conventional therapy is expected to be ...

3. openaccessgovernment.org openaccessgovernment.org/article/preparing-for-a-clinical-study-on-implant-enhance-stroke-rehabilitation/172570/

Preparing for a clinical study on implant-enhance stroke ... CorTec has developed the Brain Interchange (BIC) implant system to improve stroke rehabilitation outcomes by enhancing the effect of ...

4. researchgate.net researchgate.net/publication/379919231_Invasive_electrical_stimulation_for_stroke_treatment

Invasive electrical stimulation for stroke treatment Invasive electrical stimulation for stroke treatment The CorTec Brain Interchange system is a potential tool to improve motor rehabilitation ...

5. cortec-neuro.com cortec-neuro.com/story/one-more-stroke-project-granted-by-the-nih/

One more stroke project granted by the NIH! - CorTec Neuro About half of the patients afflicted by a stroke permanently suffer from chronic deficits in arm and hand movements. These deficits are not ameliorated by ...

6. cortec-neuro.com cortec-neuro.com/first-human-implantation-of-a-bci-made-in-germany/

First Human Implantation of a Brain-Computer Interface made ... The closed-loop BCI system, developed entirely in Germany, is currently being evaluated in an FDA-approved clinical trial with stroke patients ...

7. insights.citeline.com insights.citeline.com/medtech-insight/business/r-and-d/clinical-trials/cortec-begins-first-human-trial-of-wireless-brain-implant-for-stroke-rehab-5GRLD4I2AVCCLPCAV75UVP6TEA/

CorTec Begins First Human Trial Of Wireless Brain Implant For ... The 52-year-old man, who is recovering from multiple strokes, is participating in a clinical trial to gather initial safety data and evaluate ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11131587/

Open Mind Neuromodulation Interface for the CorTec Brain ... This paper describes the design and implementation of the OMNI-BIC software tools and demonstrates the framework's capabilities for implementing customized ...

9. massdevice.com massdevice.com/cortec-first-human-implant-bci-system/

CorTec announces first human implant for its BCI system CorTec plans for its study to gather initial safety data. It evaluates whether direct cortical electrical stimulation can enhance upper-limb ...

10. globenewswire.com globenewswire.com/news-release/2025/07/29/3123485/0/en/CorTec-Announces-Neurotech-Milestone-First-Human-Implantation-of-a-Brain-Computer-Interface-made-in-Germany.html

CorTec Announces Neurotech Milestone: First Human The closed-loop BCI system, developed entirely in Germany, is currently being evaluated in an FDA-approved clinical trial with stroke patients ...