No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
4 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for adults who have had an ischemic stroke and have upper limb impairment. Participants will receive brain stimulation therapy to help improve their recovery over 54 weeks with regular visits and follow-ups.
Are You a Good Fit for This Trial?
Rules you outHistory of spontaneous hemorrhagic strokeMajor active medical or psychiatric conditions
You may be able to join if
I am between 22 and 75 years old
I have a history of ischemic stroke
It has been at least 6 months since my stroke
I have upper limb impairment that needs treatment
I can participate in rehabilitation activities
I have an upper extremity Fugl-Myer score of 25-45
I have at least 30% preservation of corticospinal pathways on an MRI
I can produce movement in my upper limb in response to stimulation
You may not be able to join if
I cannot stop taking anti-platelet medication for 10 days around the procedure
I am on therapeutic anticoagulation medication
I have a history of deep vein thrombosis or pulmonary embolus
I have a bleeding disorder that increases the risk of complications
I have a history of seizures
I am pregnant
I have a high Geriatric Depression Score
I have significant cognitive problems that affect communication or understanding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 h…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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 …
Inclusion Criteria:
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 Criteria:
* 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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