What side effects are associated with this type of intervention?

Common treatments for ischemic stroke include thrombolytics, antiplatelet agents, anticoagulants, and mechanical thrombectomy. These treatments can have side effects such as bleeding, allergic reactions, and, in some cases, increased risk of stroke recurrence. For treatments similar to BQ 2.0, which involve non-invasive, extremely-low-intensity and low-frequency electromagnetic fields, side effects are generally minimal. Reported side effects may include mild headaches, dizziness, or local discomfort at the site of application. Overall, these non-invasive treatments are considered safe with a low risk of serious adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for ischemic stroke, primarily focusing on thrombolytic agents like tissue plasminogen activator (tPA) and mechanical thrombectomy devices. However, non-invasive treatments using electromagnetic fields, such as the BQ 2.0 device, are still under investigation and have not yet received FDA approval. These innovative approaches aim to stimulate neuronal networks to promote neurorecovery and reduce disability, representing a novel direction in stroke therapy.

What other types of research exist?

Promising alternatives to BQ 2.0 for ischemic stroke patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells and has shown benefits in motor recovery and reducing disability. 2) Transcutaneous Vagus Nerve Stimulation (tVNS), which involves stimulating the vagus nerve through the skin and has potential neuroprotective and neuroplastic effects. 3) Remote Electrical Neuromodulation (REN), which uses nonpainful electrical skin stimulation to reduce pain and improve neurological outcomes. These alternatives are supported by clinical trials and are non-invasive, making them suitable for stroke rehabilitation.

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Electromagnetic Field Treatment

Electromagnetic Field Treatment for Stroke (BQ5 Trial)

N/A

Waitlist Available

Led By Pamela W Duncan, PhD

Research Sponsored by BrainQ Technologies Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging.

Able to sit with the investigational device for 40 consecutive minutes.

Must not have

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

Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or seizure in the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 day fu visit)

Summary

This trial tests BQ 2.0, a wearable device that uses weak electromagnetic waves to help brain recovery in adults with significant disability from a stroke. The goal is to reduce disability and improve recovery by stimulating brain networks.

Who is the study for?

Adults aged 22-85 with recent ischemic stroke, moderate to severe disability including arm impairment, and able to follow simple commands. Must not be pregnant or at risk of pregnancy without contraception. Requires a caregiver for support during therapy sessions.

What is being tested?

The BQ 2.0 device is being tested for its ability to aid recovery in stroke patients by delivering low-intensity electromagnetic fields during physical and occupational therapy over a period of 9 weeks.

What are the potential side effects?

Potential side effects are not specified but may include discomfort from wearing the device or skin irritation due to adhesive materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stroke confirmed by a scan.

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I can sit still for 40 minutes with a medical device.

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I can understand and follow simple instructions.

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I am between 22 and 85 years old.

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I need some help with my daily activities due to my health condition.

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I have had a stroke confirmed by a scan.

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Before my stroke, I had no or minimal disability.

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I need some help with my daily activities due to my condition.

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I am between 22 and 85 years old.

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I was fully independent before my stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a neurological condition or physical limitation that would affect my participation in the study.

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I have active epilepsy, am on seizure medication, or had a seizure in the last 5 years.

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I have severe vision problems that cannot be fixed and would affect my participation in the study.

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I do not have a serious illness that could worsen quickly or a life expectancy under 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be assessed upon data base lock

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be assessed upon data base lock

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be assessed upon data base lock for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Modified Rankin Scale

Secondary study objectives

Change from Baseline in 10 Meter Walk Test (gait speed)

Change from Baseline in Box and Block Test (fine hand function)

Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function)

+3 more

Other study objectives

Change from Baseline in 5-level EQ-5D (health-related quality of life) at 180 days post-stroke.

Change from Baseline in Modified Rankin Scale (global disability)

Change from Baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: BQ 2.0 active stimulation groupActive Control1 Intervention

45 sessions over a period of 9 weeks (5 treatments per week) of active study intervention with BQ 2.0 including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.

Group II: BQ 2.0 sham stimulation groupPlacebo Group1 Intervention

45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 2.0 including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ischemic stroke aim to restore blood flow to the brain and reduce neuronal damage. This includes thrombolytic therapy, which dissolves blood clots, and mechanical thrombectomy, which physically removes clots. Non-invasive treatments like the BQ 2.0 device use extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields to stimulate neuronal networks. This stimulation can promote neurorecovery by enhancing neuronal plasticity and reducing disability. These mechanisms are crucial for ischemic stroke patients as they can potentially improve functional outcomes and quality of life by facilitating the recovery of impaired motor and cognitive functions.