Motor Recovery Through Plasticity-Inducing Cortical Stimulation

NCT06506279 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00019577UH3NS121565
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• Measuring upper limb impairment in stroke rehabilitation

  The primary outcome measure in the study focus on measuring upper limb impairment to ensure that the use of the CorTec Brain Interchange system is not detrimental for use in studying stimulation paradigms to improve stroke rehabilitation. Limb impairment will be assessed for all patients weekly during the rehabilitation period and at all monthly post-rehab monitoring visits using the primary behavioral measures of the study, UEFM (Upper Extremity Fuegl-Myer) arm motor score and the WMFT (Wolf Motor Function Test), which will track individual trends of motor improvement and motor function, respectively. In four subjects the degree of potentially confounding variables (such as injury and/or patient variability) will likely inhibit extrapolation of therapeutic outcomes to the stroke population at large.

  Two years

Study Arms (1)

Motor Recovery through Plasticity-Inducing Cortical Stimulation

EXPERIMENTAL

Single arm study of post-ischemic stroke patients with an upper extremity deficit.

Device: CorTec Brain Interchange (BIC) System

Interventions

CorTec Brain Interchange (BIC) System DEVICE

Surgical implantation of the BIC System. 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.

Motor Recovery through Plasticity-Inducing Cortical Stimulation

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Jeffrey Ojemann

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Anderson

CONTACT

206-744-9364; amya9@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurological Surgery

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 22, 2025
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)