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New treatment option for Ischemic Stroke
Official title EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment
ClinicalTrials.gov ID: NCT06386874
What this study is testing
- What it's testing
- This is a multicenter study that will be conducted at approximately 20 centers and up to 30 centers, if the sample size will be increased following interim assessment. The Q Therapeutic System (BQ 3.0) is a wearable medical device that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- 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.
You likely can't join if
- Hemineglect impairment (NIHSS item 11, score \>0).
- Implanted active electronic or passive MR-incompatible devices.
- Pre-existing major neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord...
- Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the...
- Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly...
- Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12...
See the full eligibility criteria
- 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...
- Informed consent signed by subject.
- Hemineglect impairment (NIHSS item 11, score \>0).
- Implanted active electronic or passive MR-incompatible devices.
- 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...
- 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
- 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...
- 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.
- Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
- Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- Employee of the Sponsor.
- Prisoner.
The study team makes the final eligibility decision.
Where it's taking place
- Downey, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Altanta, Georgia, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Edison, New Jersey, United States
- West Orange, New Jersey, United States
- Brooklyn, New York, United States
- White Plains, New York, United States
- Charlotte, North Carolina, United States
- Elkins Park, Pennsylvania, United States
- Houston, Texas, United States
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Downey, California, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States; Altanta, Georgia, United States; Chicago, Illinois, United States; Kansas City, Kansas, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.