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

Trial Summary

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.

How is the CorTec Brain Interchange (BIC) System treatment for stroke different from other treatments?

The CorTec Brain Interchange (BIC) System is unique because it involves a brain-computer interface that can potentially provide real-time communication between the brain and external devices, which is not a feature of traditional stroke treatments. This system may offer a novel approach to restoring motor function by directly interacting with brain signals, unlike standard therapies that focus on physical rehabilitation or medication. ^{1 2 3 4 5}

What is the purpose of this trial?

Using the CorTec Brain Interchange (BIC) System, we will examine the effect of a plasticity-inducing therapy regime on the rehabilitation of upper limb impairment post-stroke. This study's main objective is to implement and evaluate neuroplasticity-inducing stimulation. The stimulation methods for inducing neuroplasticity have been selected based on prior preclinical and intraoperative work that has shown promise in providing rehabilitative benefits for stroke patients. We will be structuring this study as an open prospective feasibility study.

Research Team

Jeffrey Ojemann

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Extracranial surgical procedures in the management of vertebrobasilar insufficiency. [2019]

2. Turkey pubmed.ncbi.nlm.nih.gov

Microsurgical Clipping of Complex Basilar Bifurcation Aneurysms through Different Approachs: Surgical Techniques and Results. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Robot Assisted Neurosurgery for High-Accuracy, Minimally-Invasive Deep Brain Electrophysiology in Monkeys. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Identification of the pyramidal tract by neuronavigation based on intraoperative diffusion-weighted imaging combined with subcortical stimulation. [2009]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Recovery of corticospinal tract with diffuse axonal injury: a diffusion tensor image study. [2007]