Improving motor recovery after stroke using brain stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Paired VNS: How the Brain and Pupils Respond in Stroke Patients

  This study tests real-time physiologic responses to paired VNS in adults with chronic motor impairment after ischemic stroke to help tailor dosing.

  Recruiting MGH Institute of Health Professions · Boston, Massachusetts · NCT07922200

• NeuroAiD test in mild to moderate ischemic stroke patients

  This study tests whether adding MLC901 (NeuroAiD II) to standard stroke care helps adults who recently had an ischemic stroke recover better than standard care alone.

  Recruiting Phase 4 EVD Pharmacy and Medical Company Limited · Ho Chi Minh City · NCT07828210

• Using IMPROVE to guide carotid revascularisation decisions

  This trial tests whether using the IMPROVE MRI-based score to select patients for carotid revascularisation is as good as standard care based mainly on stenosis degree, among people who have had a recent stroke or TIA due to carotid disease.

  Recruiting Maastricht University Medical Center · Arnhem, Gelderland and 9 other locations · NCT07556887

• High-intensity interval versus moderate continuous exercise for stroke-related muscle loss

  This will test whether high-intensity interval training (HIIT) or moderate-intensity continuous training (MCIT) better helps people 1–6 months after an ischemic stroke who have muscle loss regain muscle mass, strength, walking ability, and quality of life.

  Recruiting Fenerbahce University · Istanbul, Ataşehir · NCT07456956

• Test of adding a very low-dose edoxaban to standard antiplatelet therapy to prevent another stroke in adults 75 and older

  This trial tests whether adding a tiny amount of edoxaban to aspirin or clopidogrel can better prevent a second stroke in people aged 75+ who recently had an ischemic stroke.

  Recruiting Phase 3 Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT07454707

• HR-MRI–Directed Tirofiban Therapy for Late-Window ICAS-LAA Stroke

  We’re testing whether tirofiban plus dual antiplatelet therapy, guided by high-resolution MRI of the brain’s blood vessels, can help people with intracranial large-artery atherosclerosis strokes that begin more than 24 hours after onset.

  Recruiting Phase 3 Weifang Medical University · Weifang, China/Shandong Province · NCT07379190

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.