Improving motor recovery after stroke using brain stimulation
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
This study is testing a new brain stimulation device to see if it can help people recover movement in their arms after having a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06506279 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of the CorTec Brain Interchange (BIC) System on enhancing motor recovery in patients with upper limb impairments following an ischemic stroke. It aims to implement a plasticity-inducing therapy regime based on previous research that suggests neuroplasticity can aid rehabilitation. The study is designed as an open prospective feasibility study, focusing on patients who have experienced a stroke at least six months prior and exhibit specific levels of motor impairment. Participants will undergo multiple visits over a 54-week period to evaluate the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-75 who have had an ischemic stroke at least six months prior and exhibit moderate upper limb impairment.
Not a fit: Patients who are unable to participate in rehabilitation or have severe motor deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function and quality of life for stroke survivors with upper limb impairments.
How similar studies have performed: Previous studies have shown promise in using neuroplasticity-inducing methods for stroke rehabilitation, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 (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. \-
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Ojemann — University of Washington
- Study coordinator: Amy Anderson
- Email: amya9@uw.edu
- Phone: 206-744-9364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.