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Electromagnetic Field Treatment for Stroke (BQ5 Trial)
BQ5 Trial Summary
This trial is a multicenter study that will test whether the BQ 2.0, a wearable medical device that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields, can reduce disability in adult patients with subacute ischemic stroke, with a moderate to severe disability which includes an upper extremity motor impairment.
BQ5 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBQ5 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BQ5 Trial Design
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Who is running the clinical trial?
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- I had a stroke within the last 2 weeks before my most recent stroke.Your FMA-UE score for your affected arm is between 10 and 45.I have someone to help me with my physical or occupational therapy sessions over video calls.I have someone to help me with my physical or occupational therapy sessions over video calls.I have had a stroke confirmed by a scan.I can sit still for 40 minutes with a medical device.I can understand and follow simple instructions.You have a medical device that cannot be used during an MRI scan.You have a serious allergy to adhesives made from acrylic.I am between 22 and 85 years old.I do not have a neurological condition or physical limitation that would affect my participation in the study.I need some help with my daily activities due to my health condition.I have active epilepsy, am on seizure medication, or had a seizure in the last 5 years.I have severe vision problems that cannot be fixed and would affect my participation in the study.I do not have a serious illness that could worsen quickly or a life expectancy under 6 months.You are currently abusing alcohol or using illegal drugs.I am willing to do physical or occupational therapy during the study.Your impaired limb has a FMA-UE score between 10 and 45.I have had a stroke confirmed by a scan.I can sit still for 40 minutes with a medical device.I am not pregnant, breastfeeding, and either cannot become pregnant or am using birth control.I am not pregnant, breastfeeding, and either cannot become pregnant or am using birth control.I can understand and follow simple instructions.Before my stroke, I had no or minimal disability.It has been less than 3 weeks since my stroke or since I was last well.I need some help with my daily activities due to my condition.You have a severe neglect problem that could make it hard for you to do the study tasks and treatments.I am between 22 and 85 years old.I am willing to do physical or occupational therapy during the study.It has been 4 to 21 days since my stroke occurred.I was fully independent before my stroke.
- Group 1: BQ 2.0 sham stimulation group
- Group 2: BQ 2.0 active stimulation group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What results are researchers expecting to arise from this trial?
"The primary outcome of this study, spanning from 4-10 days post stroke to 90 days after the incident, is an alteration in Modified Rankin Score. As secondary goals, researchers seek a decrease in upper limb impairment (assessed by EQ-5D-5L), improvement of fine hand function (measured with Box and Block Test) as well as a quicker gait speed (as determined by 10 Meter Walk Test)."
What criteria must be met to qualify for enrollment in this clinical trial?
"This investigation is accepting 78 patients with wake-up stroke between the ages of 22 and 80. To qualify, participants must have a Modified Rankin Scale (mRS) score of 3 or 4, a pre-stroke mRS score of 0 or 1, an Fugl Meyer Assessment - Upper Extremity (FMA-UE) score within 10 to 45 range , be able to follow a three step command such as "take the paper, fold it in half and return it to me", agree to partake in occupational/physical therapy activities during treatment sessions via video call alongside their relative or caregiver who are available for assistance throughout this trial"
Does this research encompass the elderly demographic?
"As set forth in the participation requirements, individuals must be between 22 and 80 years old to qualify for this medical study."
How many participants are currently enrolled in this clinical experiment?
"To complete the trial, 78 qualified participants need to register. Those eligible can join in from either Moss Rehabilitation Research Institute (Elkins Park, Pennsylvania) or Ronald Reagan UCLA Medical Center & California Rehabilitation Institute (Los Angeles, California)."
Is there room to join this experiment?
"This experiment is actively seeking participants, as indicated on clinicaltrials.gov. It was originally posted on December 4th 2021 and last edited on August 10th 2022."
How many medical centers are currently involved in this clinical trial?
"The list of available clinical trial sites includes Moss Rehabilitation Research Institute in Elkins Park, Ronald Reagan UCLA Medical Center & California Rehabilitation Institute in Los Angeles, and Baylor Scott & White Institute for Rehabilitation in Dallas. 11 other medical facilities are also participating."
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