Motor Recovery Through Plasticity-Inducing Cortical Stimulation

Exclusion Criteria24

• 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
• 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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