The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)

Prior treatment

• Previous ischemic or hemorrhagic stroke within the 2 weeks before the index stroke.
• Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or seizure in the last 5 years.
• Ongoing alcohol abuse and/or illicit drug use.

Other illness

• Severe neglect impairment (NIHSS item 11 score = 2) or neglect that is severe enough to interfere with reasonable performance of study procedures. assessments or treatments.
• Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
• Unstable serious illness/condition (eg, active cancer, severe heart failure, active psychiatric condition) or life expectancy of less than 6 12 months.
• A known severe allergic reaction to acrylic-based adhesives.

Other

• Implanted active electronic or passive MR-incompatible devices.
• Significant visual disturbances that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
• Employee of the Sponsor.
• Prisoner.

• mRS score of 3 or 4.
• FMA-UE score between 10-45 (inclusive) of impaired limb.
• Age 22 to 85 years of age (inclusive).
• Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging.
• 4 to 21 days from stroke onset (or last known well).
• Pre-stroke mRS of 0 or 1.
• Able to sit with the investigational device for 40 consecutive minutes.
• Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
• Willingness to participate in occupational/physical therapy activities during study intervention sessions.
• Availability of a relative or other caregiver able to assist during PT/OT treatment delivered via video call sessions during the study.
• If female, not pregnant (as confirmed by a urine or a blood test, or as determined by an official medical document) or breastfeeding and with no ability to become pregnant or on an acceptable method of contraception during the study
• Informed consent signed by subject (if competent) or legally authorized representative.