Actively Recruiting
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
Led by University of Washington · Updated on 2026-04-13
4
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 75 years
- History of ischemic stroke
- At least 6 months since ischemic cortical stroke
- Hemiparesis requiring surgical intervention for upper limb impairment
- Able to participate meaningfully in rehabilitation with upper extremity Fugl-Myer score of 25-45
- Disability level between 3 and 4 on the modified Rankin Scale
- At least 30% preservation of corticospinal pathways on MRI
- Observable upper limb motor response to transcranial magnetic stimulation
- Available for 54 weeks of multiple study visits (38 weeks implanted, 16 weeks post-explant follow-up)
- All criteria assessed within 90 days before device implantation, with possible exceptions for MRI review
You will not qualify if you...
- Unable to stop anti-platelet medication 7 days before and 3 days after surgery
- Receiving therapeutic anticoagulation
- History of unprovoked deep vein thrombosis or pulmonary embolism
- Bleeding disorder increasing hemorrhage risk with study procedures
- Other medical history indicating increased thrombosis risk as judged by investigators
- History of seizures
- Pregnancy
- Geriatric Depression Score over 10
- Montreal Cognitive Assessment below 22 unless due to aphasia and approved by investigator
- Columbia Suicide Scale ideation score above 1
- Aphasia or cognitive deficits preventing communication of pain or understanding of tasks
- Severe neglect as measured by NIH Stroke Scale question 11 score of 2
- Cardiac conditions increasing safety risk
- History of spontaneous hemorrhagic stroke
- Major active neurological, psychiatric, or medical conditions interfering with study
- Active infection requiring antimicrobial therapy
- Unable to participate in proposed rehabilitation
- Presence of other implanted devices (pacemakers, cochlear implants, etc.)
- Need for occupational, physical, or speech therapy outside the study protocol
- Additional screening needed for shoulder conditions causing pain
- Any other medication or condition that may affect study integrity as determined by clinical staff
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
A
Amy Anderson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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