RECRUITING

Motor Recovery Through Plasticity-Inducing Cortical Stimulation

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Conditions

Stroke, Ischemic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Motor Recovery Through Plasticity-Inducing Cortical Stimulation

Quick Facts

Study Start:2025-01-31
Study Completion:2030-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06506279

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of ischemic stroke
  2. * Minimum 6 months post-ischemic cortical stroke
  3. * Levels of hemiparesis that warrant surgical intervention (upper limb impairment)
  4. * Able to participate in a meaningful way in rehabilitation (defined by upper extremity Fugl-Myer (UEFM) score of 25-45
  5. * Disability measured between 3 and 4 on the modified Rankin Scale
  6. * Minimum of 30% preservation of the corticospinal pathways in MRI imaging
  7. * Observable motor output of the upper limb in response to TMS delivered to the motor cortex
  8. * Available for the duration of the study, 54 weeks for multiple visits (38 weeks implanted and 16 weeks post-explant follow-up).
  9. * 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).
  1. * Unable to discontinue anti-platelet medication for 7 days pre- and 3 days post-op
  2. * On therapeutic anticoagulation
  3. * A history of unprovoked deep vein thrombosis or any pulmonary embolus
  4. * The presence of a bleeding disorder which significantly increases the chances that the patient will have a hemorrhagic complication in relation to study procedures.
  5. * Other medical history indicating increased risk of thrombosis per investigator discretion
  6. * Any history of seizures
  7. * Pregnancy
  8. * Geriatric Depression Score greater than 10
  9. * Montreal Cognitive Assessment below 22 unless attributable to aphasia and approved by PI
  10. * Columbia Suicide Scale ideation score above 1
  11. * Aphasia or cognitive deficits substantial enough to prevent:
  12. * communication of pain and discomfort due to study procedures
  13. * understanding of motor testing or rehabilitation tasks
  14. * 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."
  15. * Cardiac morbidity that in the judgment of the investigators would represent an increased safety risk
  16. * History of spontaneous hemorrhagic stroke
  17. * Major, active neurological, psychiatric, or medical comorbidity that would likely interfere with study procedures
  18. * Any active infection requiring antimicrobial therapy
  19. * Inability to participate with proposed rehabilitation strategies
  20. * Presence of any other implanted devices (cochlear implants, pacemakers, etc.).
  21. * 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
  22. * 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).

Contacts and Locations

Study Contact

Amy Anderson
CONTACT
206-744-9364
amya9@uw.edu

Principal Investigator

Jeffrey Ojemann
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Jeffrey Ojemann, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31
Study Completion Date2030-06-15

Study Record Updates

Study Start Date2025-01-31
Study Completion Date2030-06-15

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke, Ischemic