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Wearable device treatment for ischemic stroke recovery

The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (the "EMAGINE 2.0" Study)

Not applicable Interventional BrainQ Technologies Ltd. · NCT06386874

This study is testing a wearable device that uses electromagnetic fields to help people recovering from ischemic stroke improve their function and reduce disability.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment122 (estimated)
Ages22 Years to 80 Years
SexAll
SponsorBrainQ Technologies Ltd. Industry-sponsored
Locations14 sites (Downey, California and 13 other locations)
Trial IDNCT06386874 on ClinicalTrials.gov

What this trial studies

This multicenter clinical trial evaluates the Q Therapeutic System (BQ 3.0), a wearable device that delivers non-invasive electromagnetic fields to stimulate neuronal networks in patients recovering from ischemic stroke. Participants will be randomly assigned to receive either active treatment or sham treatment, with sessions occurring up to five times a week for a total of 45 to 72 treatments over a 90-day period. The study aims to assess the device's effectiveness in reducing disability and promoting neurorecovery in stroke patients. Additionally, participants will engage in a home-based exercise program to complement the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 80 who are 4 to 21 days post-stroke and have specific mobility and neurological assessment scores.

Not a fit: Patients with severe neurological impairments or those who have had multiple strokes with residual disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance recovery outcomes for patients suffering from ischemic stroke.

How similar studies have performed: While the approach of using electromagnetic fields for stroke recovery is innovative, similar studies have shown promise in related areas, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. mRS score of 3 or 4.
2. FMA-UE score between 10-45 (inclusive) of impaired limb.
3. SAFE score \>0.
4. Age 22 to 80 years of age (inclusive).
5. Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.
6. 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.
7. Four to 21 days from stroke onset (or last known well).
8. Pre-stroke mRS of 0.
9. Able to sit with the investigational device for 40 consecutive minutes, in the opinion of the investigator or designee.
10. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
11. Willingness to participate in an exercise activity during study intervention sessions.
12. 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.
13. 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
14. Informed consent signed by subject.

Exclusion Criteria:

1. Hemineglect impairment (NIHSS item 11, score \>0).
2. Implanted active electronic or passive MR-incompatible devices.
3. 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.
4. 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
5. 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.
6. Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
7. A known severe allergic reaction to acrylic-based adhesives.
8. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
9. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
10. Employee of the Sponsor.
11. Prisoner.

Where this trial is running

Downey, California and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic Stroke
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.