EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

Korábbi kezelés

• Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years
• Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.

Más betegség

• Hemineglect impairment (NIHSS item 11, score >0).
• Pre-existing major neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or pre-existing physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
• Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and 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 major psychiatric condition) or life expectancy of less than 12 months.
• A known severe allergic reaction to acrylic-based adhesives.

Egyéb

• Implanted active electronic or passive MR-incompatible devices.
• 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.
• SAFE score >0.
• Age 22 to 80 years of age (inclusive).
• Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.
• First ever ischemic stroke, or a recurring ischemic stroke6 occurring at least 3 months after the previous stroke (any stroke), without residual neurological impairment or disability before current stroke.
• Four to 21 days from stroke onset (or last known well).
• Pre-stroke mRS of 0.
• Able to sit with the investigational device for 40 consecutive minutes, in the opinion of the investigator or designee.
• Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
• Willingness to participate in an exercise activity during study intervention sessions.
• Availability of a relative or other caregiver able to assist in operating an application installed on a mobile device, including a video call, and assist the participant with the exercising program.
• 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.