Ischemic StrokeNCT06386874
EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment
A study testing Q Therapeutic System (BQ 3.0) - Active in people with Ischemic Stroke, run by BrainQ Technologies Ltd. at 14 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Q Therapeutic System (BQ 3.0) - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 14 sitesUnited States
- Study dates
- 20 Aug 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 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 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 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.
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Not yet recruiting
Emory University School of Medicine
Altanta, Georgia, 30322
Susan Murphy, CCRC, 404-727-5630, smurph7@emory.edu
Michael R Borich, DPT, PhD
- Not yet recruiting
New York-Presbyterian Brooklyn Methodist Hospital Inpatient Rehabilitation Unit
Brooklyn, New York, 11215
Mahika Rathod, BS, 646-697-7342, mar4053@med.cornell.edu
Jason Edwards, DO
- Recruiting
Atrium Health Carolinas Rehabilitation
Charlotte, North Carolina, 28203
Tami Guerrier, CRA, 704-822-2550, Tami.Guerrier@atriumhealth.org
Tamala Meeks, Tamala.Meeks@atriumhealth.org
- Not yet recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Sara Prokup, PT, DPT, 312-238-1000, sprokup@ricres.org
Elliot Roth, MD
- Recruiting
Rancho Research Institute
Downey, California, 90242
Nicole Bayus, MA, (562) 385-8111, NicoleB@ranchoresearch.org
Susan Shaw Huang, MD
- Recruiting
Hackensack Meridian JFK Johnson Rehabilitation Institute
Edison, New Jersey, 08818
Maria Montealegre, OTD, 732-321-7050, maria.montealegre@hmhn.org
Sara Cuccurullo, MD
- Not yet recruiting
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
Tori Sprowl, 215-663-6043, Tori.Sprowl@jefferson.edu
Jaclyn Barcikowski, DO
- Not yet recruiting
UTHealth Houston
Houston, Texas, 77030
Emily Stevens, MOT,OTR,CSRS, (713) 500-7914, Emily.A.Stevens@uth.tmc.edu
Sean Savitz, MD
- Not yet recruiting
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
Hannah Snyder, MS, (904) 345-7600, Hannah.Snyder@Brooksrehab.org
Emily Fox, PT, PhD
- Recruiting
KUMC- KU Medical Center
Kansas City, Kansas, 66160
Sasha Moors, CCRP, 913-588-2697, smoores@kumc.edu
Bria Bartsch, bbartsch@kumc.edu
- Not yet recruiting
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Alan Young, 414-805-3000, alyoung@mcw.edu
Charlotte Ball, MD
- Recruiting
MedStar National Rehabililtaion Hospital,
Washington D.C., District of Columbia, 20010
Kathaleen Brady, Kathaleen.P.Brady@medstar.net
Richard Zorowitz, MD
- Recruiting
Kessler Foundation for Rehabilitation
West Orange, New Jersey, 07052
Ghaith J Androwis, PhD, 973-324-3565, GAndrowis@kesslerfoundation.org
Steven Kirshblum, MD
- Recruiting
Burke Rehabilitation Hospital
White Plains, New York, 10605
Josette Hartnett, MPH, 914-597-2500, johartnett@burke.org
Andrew K Abdou, DO
About this study
Official title: 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)
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.
Read more
The Q Therapeutic System (BQ 3.0) is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies.
- In Stage 1 (starting 4-21 days after the index stroke event to day 90 post stroke), participants will be randomly assigned (1:1) to receive either active or the sham treatments, up to 5 times a week, and at least to a total of 45 treatments.
- In Stage 2 (day 90 to day 180 post stroke), participants in both the active and the control group will be allowed to continue to receive active treatments, up to 5 times per week.
- In stage 3 (day 180 to day 270 post stroke), participants will not receive any treatments and would be followed up until the final visit at day 270.
Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program. Treatments may be administered in the hospital, in the clinic or in a home setting.
The study will enroll 100-122 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using the BQ 3.0 system.
Read the detailed description
The study intervention will be initiated 4-21 days after the index stroke event and will consist of 5 treatments per week until the primary endpoint follow-up visit, at day 90 (±15) after the onset of the index stroke. A minimum of 45 treatment sessions should be completed during this stage, with a potential of a maximum of 72 treatment sessions, depending on the start date of the first treatment and the timing of the 90-day follow-up visit. Though, participants and sites will be guided to conduct the 90 days follow-up visit as soon as possible after the 45th treatment session and within up to 7 days from the 45th treatment and after the window opening.
Each treatment session will last approximately 60 minutes and include 40 minutes of active or sham stimulation. Subjects in both groups will be asked to perform a home-based exercise program for the upper and the lower limb, concurrent with the study intervention.
Screening phase:
Prospective subjects, who are 3 to 21 days post-stroke, may be offered informed consent to participate in the study at either:
a participating inpatient or outpatient center, non-participating inpatient or outpatient center, in accordance with both the participating and the non-participating centers' policy, or home Consented subjects, who are 4 to 21 days post-stroke, will be screened for eligibility to participate in the treatment phase of the study.
Eligible subjects will be randomly assigned, at a 1:1 allocation ratio, to either the active or sham study intervention groups.
Stimulation with the Q Therapeutic System (BQ 3.0) does not produce any noticeable sound, light, or tactile sensation which could disclose the treatment arm assignment, making this device ideal for testing in a sham-controlled design. During sham treatment sessions, for purposes of maintaining the blind, the device will function as if it is delivering the therapy (i.e., the device will turn on and all indicators will function), but the frequency and intensity parameters, which are not visible to the subject or site study members (or any blinded personnel), will be set to zero so that no stimulation is delivered.
Stage 1 (day 4 to day 90 (±15) post-stroke) - double-blind sham-controlled:
Efforts should be made to initiate the 1st treatment as early as possible within the window of recruitment, and target to complete a first treatment within 6 days from admission to a participating IRF (where applicable). The study intervention will be initiated 4-21 days after the index stroke event and will consist of 5 treatments per week until the primary endpoint follow-up visit, at day 90 (±15) after the onset of the index stroke. Each treatment session will last approximately 60 minutes and include 40 minutes of active or sham stimulation. Subjects in both groups will be asked to perform a home- based exercise program for the upper and the lower limb, concurrent with the study intervention. The program will be standardized, pre-defined, home-based, and aligned with standard-of-care1.
The participant and their caregiver will be trained on the use of the device and exercise program. Treatment sessions will be completed by the subject with the assistance of a trained caregiver, as needed. Periodic supervision will be provided by the study team (combined audio and video remote conferencing or audio only, if video is not available). A sponsor's representative may provide in-person or remote technical support to the participant and their caregiver, as well as device training, as needed.
Subjects will undergo a detailed interim outcome assessment on the 45th (±4) day after the onset of the index stroke, and a detailed primary endpoint outcome assessment on the 90th (±15) day after the onset of the index stroke. In addition, a focused, long-term outcome assessment on the 180th (±15) day after the onset of the index stroke will be performed.
Stage 2 (day 90 (±15) to day 180 (±15) post-stroke) - open-label:
Subjects in both the active and the sham groups (active /sham), who were adherent to the treatment in Stage 1 (defined as at least 35 completed treatment sessions in Stage 1) will be allowed to continue to receive active EMFstimulation treatments (i.e., with the electromagnetic therapy turned on).
Up to 5 active treatments per week will be completed, starting following the primary endpoint assessment follow-up visit at 90 (±15) days after the onset of the index stroke and continuing until the follow-up visit at 180 (±15) days after the onset of the index. Technically, a maximum of 86 treatment sessions can be completed during stage 2, depending on the timing of the 90-day and 180-day follow-up visits.
The blind, with respect to the group allocation in Stage 1, would be maintained for all parties (participants, investigators, assessors and Sponsor) until the trial completion and database lock.
Each session will last approximately 60 minutes and include 40 minutes of active stimulation. Subjects will be asked to perform a home-based exercise program, concurrent with the study intervention.
Treatment sessions will be completed by the subject with the assistance of a trained caregiver, as needed. Periodic supervision will be provided by the study team (combined audio and video remote conferencing or audio only, if video is not available). A sponsor's representative willmay provide in-person or remote technical support to the participant and their caregiver, as well as device training, as needed.
All subjects, including those who decided not to continue to receive treatments in Stage 2, will undergo a detailed follow-up assessment on the 180th (±15) day after the onset of the index stroke.
Stage 3 (day 180 (±15) to day 270 (±15) post-stroke):
At this Stage, no treatments sessions will take place. All subjects, including those who decided not to continue to receive treatments in Stage 2, will undergo In addition, aa focused, long-term outcome assessment on the 180th 270th (±15) day after the onset of the index stroke will be performed.
Any adverse events and device deficiencies occurring during the period of subject's participation in the trial will be recorded.
Participation in the study will not replace any of the usual care patient should receive.
- Conditions
- Ischemic Stroke
- Being tested
- Q Therapeutic System (BQ 3.0) - Sham, Q Therapeutic System (BQ 3.0) - Active
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q Therapeutic System (BQ 3.0) - ShamDevice
Also called BQ 3.0 Sham Stimulation Group
The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. Frequency and intensity parameters will be set to zero so that no stimulation is delivered.
Q Therapeutic System (BQ 3.0) - ActiveDevice
Also called BQ 3.0 Active Stimulation Group Interventions
The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery
| Study group | Role | What they receive |
|---|---|---|
| BQ 3.0 Sham Stimulation Group | Sham comparator | Q Therapeutic System (BQ 3.0) sham stimulation group:
Device used: Q Therapeutic System (BQ 3.0)
In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 3.0 (frequency and intensity parameters will be set to zero so that no stimulation is delivered) including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention. Receives: Device: Q Therapeutic System (BQ 3.0) - Sham; Device: Q Therapeutic System (BQ 3.0) - Active |
| BQ 3.0 Active Stimulation Group | Active comparator | Q Therapeutic System (BQ 3.0) active stimulation group:
Device used: Q Therapeutic System (BQ 3.0)
In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of active study intervention with the BQ 3.0 (frequency and intensity parameters will be set to 1-100 Hz.; 0.1-1.0 G), including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention. Receives: Device: Q Therapeutic System (BQ 3.0) - Sham; Device: Q Therapeutic System (BQ 3.0) - Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Modified Rankin Scale
Proportion of subjects achieving an excellent outcome defined as a Modified Rankin Scale (mRS) score of 0-1 at the 90-day post-stroke assessment, reflecting freedom from disability.
Measured: 4 to 21 days following an ischemic stroke to 90-day post-stroke
Secondary outcomes (16)
Ordinal shift analysis of the mRS (trichotomized at 0-1, 2, 3-6) (Key Secondary Effectiveness Endpoint)
Measured: baseline to the 90-day post-stroke assessment
Change from Baseline in Modified Rankin Scale (Key Secondary Effectiveness Endpoint)
To show that the BQ therapy is effective in reducing disability levels
Measured: baseline (4-21 days post-stroke) to 90 days post-stroke
Proportion of subjects achieving functional independence (mRS score of 0-2) (Key Secondary Effectiveness Endpoint)
To show that the BQ therapy is effective in achieving functional independence.
Measured: at the 90-day post-stroke assessment
Stroke Impact Scale Hand Domain (Lead Secondary Endpoint)
Patient reported hand function - To show that the BQ therapy is effective in improving upper limb impairment and function
Measured: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
Stroke Impact Scale 16
Patient-reported physical function - To show that the BQ therapy is effective in improving physical function
Measured: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
10-meter Walk Test
The Functional Ambulation Categories (FAC) will be collected concurrent to the 10MWT to assess the level of independent ambulation.
Measured: change from baseline to 90 days post-stroke
Box and Block Test
Arm motor function - To show that the BQ therapy is effective in improving Arm motor function
Measured: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
Evaluation of 5-level EQ-5D
Health-related quality of life - To show that the BQ therapy is effective in achieving health-related quality of life (HRQoL)
Measured: At 90-days post-stroke
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
upper limb impairment - To show that the BQ therapy is effective in achieving reducing upper limb impairment, and improving upper limb function
Measured: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
Nine-Hole Peg Test
finger dexterity - To show that the BQ therapy is effective in achieving reducing upper limb impairment, and improving upper limb function
Measured: change from baseline to 90-days post-stroke
The proportion of subjects within those in the active group who continued to receive treatments in Stage 2, achieving an excellent outcome (defined as a mRS of 0-1) at the 180-day post-stroke assessment.
To show, within those in the active group who continued to receive treatments in Stage 2, that the BQ therapy is effective in attaining freedom from disability, as well as reducing global disability, at 6 months post-stroke in disabled patients when initiated 4 to 21 days following an ischemic stroke.
Measured: at the 180-day post-stroke assessment
The proportion of patients within those in the active group who continued to receive treatments in Stage 2, who achieved an excellent outcome defined as a mRS score of 0-1 at the 90-day post-stroke assessment and had an mRS >1 at 180-day post-stroke
To show, within those in the active group who continued to receive treatments in Stage 2, that the BQ therapy is effective in attaining freedom from disability, as well as reducing global disability, at 6 months post-stroke in disabled patients when initiated 4 to 21 days following an ischemic stroke
Measured: at 180 days post-stroke
The proportion of patients within those in the active group who continued to receive treatments in Stage 2, who achieved an excellent outcome defined as mRS score of 0-1 at the 180-day post-stroke assessment and had an mRS >1 at 270 days post-stroke.
To show, within those in the active group who continued to receive treatments in Stage 2, that the effect attained in obtaining freedom from disability, as well as reducing global disability, is maintained at 6- and 9- months post-stroke in disabled patients with upper limb motor impairment when initiated 4 to 21 days following an ischemic stroke.
Measured: at 270 days post-stroke
Ordinal shift analysis of the mRS (4 levels at 0, 1, 2, 3-6) from the 90-day post-stroke assessment to 180-day post-stroke assessment, within those in the active group who continued to receive treatments in Stage 2
Measured: from the 90-day post-stroke assessment to 180-day post-stroke assessment
The proportion of patients who improved by at least 1 level on the mRS from the 90-day post-stroke assessment to 180-day post-stroke assessment, within those in the active group who continued to receive treatments in Stage 2.
To show, within those in the active group who continued to receive treatments in Stage 2, that the BQ therapy is effective in attaining freedom from disability, as well as reducing global disability, at 6 months post-stroke in disabled patients when initiated 4 to 21 days following an ischemic stroke
Measured: from the 90-day post-stroke assessment to 180-day post-stroke assessment
The proportion of subjects within those in the sham group who continued to receive treatments in Stage 2, achieving an excellent outcome (defined as a mRS of 0-1) at the 180-day post-stroke assessment, and had an mRS >1 at 90 days post-stroke.
To show, within those in the sham group who continued to receive treatments in Stage 2 that the BQ therapy is effective in attaining freedom from disability, as well as reducing global disability, at 6 months post-stroke in disabled patients when initiated 90 days following an ischemic stroke
Measured: from the 90-day assessment to the 180-day assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start20 Aug 2024
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using the BQ3. system
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrainQ Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey L. Saver, MD, Study chair, Coordinating PIJoel Stein, MD, Principal investigator, Coordinating PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386874
- Sponsor's protocol ID
- BQ7
- Status last verified
- Nov 2024
- First submitted
- 16 Apr 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: will be shared following site level approval
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06386874
- Acronym / sponsor ID
- BQ7
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- BrainQ Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The Q Therapeutic System (BQ 3.0) is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies.
- In Stage 1 (starting 4-21 days after the index stroke event to day 90 post stroke), participants will be randomly assigned (1:1) to receive either active or the sham treatments, up to 5 times a week, and at least to a total of 45 treatments.
- In Stage 2 (day 90 to day 180 post stroke), participants in both the active and the control group will be allowed to continue to receive active treatments, up to 5 times per week.
- In stage 3 (day 180 to day 270 post stroke), participants will not receive any treatments and would be followed up until the final visit at day 270.
Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program. Treatments may be administered in the hospital, in the clinic or in a home setting.
The study will enroll 100-122 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using the BQ 3.0 system.
Detailed description
The study intervention will be initiated 4-21 days after the index stroke event and will consist of 5 treatments per week until the primary endpoint follow-up visit, at day 90 (±15) after the onset of the index stroke. A minimum of 45 treatment sessions should be completed during this stage, with a potential of a maximum of 72 treatment sessions, depending on the start date of the first treatment and the timing of the 90-day follow-up visit. Though, participants and sites will be guided to conduct the 90 days follow-up visit as soon as possible after the 45th treatment session and within up to 7 days from the 45th treatment and after the window opening.
Each treatment session will last approximately 60 minutes and include 40 minutes of active or sham stimulation. Subjects in both groups will be asked to perform a home-based exercise program for the upper and the lower limb, concurrent with the study intervention.
Screening phase:
Prospective subjects, who are 3 to 21 days post-stroke, may be offered informed consent to participate in the study at either:
a participating inpatient or outpatient center, non-participating inpatient or outpatient center, in accordance with both the participating and the non-participating centers' policy, or home Consented subjects, who are 4 to 21 days post-stroke, will be screened for eligibility to participate in the treatment phase of the study.
Eligible subjects will be randomly assigned, at a 1:1 allocation ratio, to either the active or sham study intervention groups.
Stimulation with the Q Therapeutic System (BQ 3.0) does not produce any noticeable sound, light, or tactile sensation which could disclose the treatment arm assignment, making this device ideal for testing in a sham-controlled design. During sham treatment sessions, for purposes of maintaining the blind, the device will function as if it is delivering the therapy (i.e., the device will turn on and all indicators will function), but the frequency and intensity parameters, which are not visible to the subject or site study members (or any blinded personnel), will be set to zero so that no stimulation is delivered.
Stage 1 (day 4 to day 90 (±15) post-stroke) - double-blind sham-controlled:
Efforts should be made to initiate the 1st treatment as early as possible within the window of recruitment, and target to complete a first treatment within 6 days from admission to a participating IRF (where applicable). The study intervention will be initiated 4-21 days after the index stroke event and will consist of 5 treatments per week until the primary endpoint follow-up visit, at day 90 (±15) after the onset of the index stroke. Each treatment session will last approximately 60 minutes and include 40 minutes of active or sham stimulation. Subjects in both groups will be asked to perform a home- based exercise program for the upper and the lower limb, concurrent with the study intervention. The program will be standardized, pre-defined, home-based, and aligned with standard-of-care1.
The participant and their caregiver will be trained on the use of the device and exercise program. Treatment sessions will be completed by the subject with the assistance of a trained caregiver, as needed. Periodic supervision will be provided by the study team (combined audio and video remote conferencing or audio only, if video is not available). A sponsor's representative may provide in-person or remote technical support to the participant and their caregiver, as well as device training, as needed.
Subjects will undergo a detailed interim outcome assessment on the 45th (±4) day after the onset of the index stroke, and a detailed primary endpoint outcome assessment on the 90th (±15) day after the onset of the index stroke. In addition, a focused, long-term outcome assessment on the 180th (±15) day after the onset of the index stroke will be performed.
Stage 2 (day 90 (±15) to day 180 (±15) post-stroke) - open-label:
Subjects in both the active and the sham groups (active /sham), who were adherent to the treatment in Stage 1 (defined as at least 35 completed treatment sessions in Stage 1) will be allowed to continue to receive active EMFstimulation treatments (i.e., with the electromagnetic therapy turned on).
Up to 5 active treatments per week will be completed, starting following the primary endpoint assessment follow-up visit at 90 (±15) days after the onset of the index stroke and continuing until the follow-up visit at 180 (±15) days after the onset of the index. Technically, a maximum of 86 treatment sessions can be completed during stage 2, depending on the timing of the 90-day and 180-day follow-up visits.
The blind, with respect to the group allocation in Stage 1, would be maintained for all parties (participants, investigators, assessors and Sponsor) until the trial completion and database lock.
Each session will last approximately 60 minutes and include 40 minutes of active stimulation. Subjects will be asked to perform a home-based exercise program, concurrent with the study intervention.
Treatment sessions will be completed by the subject with the assistance of a trained caregiver, as needed. Periodic supervision will be provided by the study team (combined audio and video remote conferencing or audio only, if video is not available). A sponsor's representative willmay provide in-person or remote technical support to the participant and their caregiver, as well as device training, as needed.
All subjects, including those who decided not to continue to receive treatments in Stage 2, will undergo a detailed follow-up assessment on the 180th (±15) day after the onset of the index stroke.
Stage 3 (day 180 (±15) to day 270 (±15) post-stroke):
At this Stage, no treatments sessions will take place. All subjects, including those who decided not to continue to receive treatments in Stage 2, will undergo In addition, aa focused, long-term outcome assessment on the 180th 270th (±15) day after the onset of the index stroke will be performed.
Any adverse events and device deficiencies occurring during the period of subject's participation in the trial will be recorded.
Participation in the study will not replace any of the usual care patient should receive.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using the BQ3. system
| Arm | Type | Receives |
|---|---|---|
| BQ 3.0 Sham Stimulation Group | Sham comparator | Device: Q Therapeutic System (BQ 3.0) - Sham, Device: Q Therapeutic System (BQ 3.0) - ActiveQ Therapeutic System (BQ 3.0) sham stimulation group: Device used: Q Therapeutic System (BQ 3.0) In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 3.0 (frequency and intensity parameters will be set to zero so that no stimulation is delivered) including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention. |
| BQ 3.0 Active Stimulation Group | Active comparator | Device: Q Therapeutic System (BQ 3.0) - Sham, Device: Q Therapeutic System (BQ 3.0) - ActiveQ Therapeutic System (BQ 3.0) active stimulation group: Device used: Q Therapeutic System (BQ 3.0) In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of active study intervention with the BQ 3.0 (frequency and intensity parameters will be set to 1-100 Hz.; 0.1-1.0 G), including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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 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 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 neurological or functional evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q Therapeutic System (BQ 3.0) - ShamAlso: BQ 3.0 Sham Stimulation GroupThe BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. Frequency and intensity parameters will be set to zero so that no stimulation is delivered. | Device | BQ 3.0 Active Stimulation Group, BQ 3.0 Sham Stimulation Group |
| Q Therapeutic System (BQ 3.0) - ActiveAlso: BQ 3.0 Active Stimulation Group InterventionsThe BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery | Device | BQ 3.0 Active Stimulation Group, BQ 3.0 Sham Stimulation Group |
Primary outcome
Change from Baseline in Modified Rankin Scale
Time frame: 4 to 21 days following an ischemic stroke to 90-day post-stroke
Proportion of subjects achieving an excellent outcome defined as a Modified Rankin Scale (mRS) score of 0-1 at the 90-day post-stroke assessment, reflecting freedom from disability.
16 secondary outcomes
Ordinal shift analysis of the mRS (trichotomized at 0-1, 2, 3-6) (Key Secondary Effectiveness Endpoint)
Time frame: baseline to the 90-day post-stroke assessment
Change from Baseline in Modified Rankin Scale (Key Secondary Effectiveness Endpoint)
Time frame: baseline (4-21 days post-stroke) to 90 days post-stroke
Proportion of subjects achieving functional independence (mRS score of 0-2) (Key Secondary Effectiveness Endpoint)
Time frame: at the 90-day post-stroke assessment
Stroke Impact Scale Hand Domain (Lead Secondary Endpoint)
Time frame: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
Stroke Impact Scale 16
Time frame: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
10-meter Walk Test
Time frame: change from baseline to 90 days post-stroke
Box and Block Test
Time frame: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
Evaluation of 5-level EQ-5D
Time frame: At 90-days post-stroke
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke
Nine-Hole Peg Test
Time frame: change from baseline to 90-days post-stroke
The proportion of subjects within those in the active group who continued to receive treatments in Stage 2, achieving an excellent outcome (defined as a mRS of 0-1) at the 180-day post-stroke assessment.
Time frame: at the 180-day post-stroke assessment
The proportion of patients within those in the active group who continued to receive treatments in Stage 2, who achieved an excellent outcome defined as a mRS score of 0-1 at the 90-day post-stroke assessment and had an mRS >1 at 180-day post-stroke
Time frame: at 180 days post-stroke
The proportion of patients within those in the active group who continued to receive treatments in Stage 2, who achieved an excellent outcome defined as mRS score of 0-1 at the 180-day post-stroke assessment and had an mRS >1 at 270 days post-stroke.
Time frame: at 270 days post-stroke
Ordinal shift analysis of the mRS (4 levels at 0, 1, 2, 3-6) from the 90-day post-stroke assessment to 180-day post-stroke assessment, within those in the active group who continued to receive treatments in Stage 2
Time frame: from the 90-day post-stroke assessment to 180-day post-stroke assessment
The proportion of patients who improved by at least 1 level on the mRS from the 90-day post-stroke assessment to 180-day post-stroke assessment, within those in the active group who continued to receive treatments in Stage 2.
Time frame: from the 90-day post-stroke assessment to 180-day post-stroke assessment
The proportion of subjects within those in the sham group who continued to receive treatments in Stage 2, achieving an excellent outcome (defined as a mRS of 0-1) at the 180-day post-stroke assessment, and had an mRS >1 at 90 days post-stroke.
Time frame: from the 90-day assessment to the 180-day assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No. will be shared following site level approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey L. Saver, MD study chair
Coordinating PI
Joel Stein, MD principal investigator
Coordinating PI
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q Therapeutic System (BQ 3.0) - Active in people with Ischemic Stroke, run by BrainQ Technologies Ltd. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assaf Lifshitz (9720544586787, assaf@brainqtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Modified Rankin Scale (time frame: 4 to 21 days following an ischemic stroke to 90-day post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.