Status:
RECRUITING
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke, Ischemic
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
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 object...
Detailed Description
Stroke is one of the top three causes of human disability. In middle- and high-income countries around the world, stroke is the leading neurological cause of lost disability-adjusted life years. Motor...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2030
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06506279
Start Date
July 1 2025
End Date
June 15 2030
Last Update
May 14 2025
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98104