Ischemic StrokeBQ5NCT05044507
The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)
A study testing BQ 2.0 in people with Ischemic Stroke, run by BrainQ Technologies Ltd. at 15 sites in United States.
Trial summary
This is a multicenter study that will be conducted at approximately 20 centers. BQ 2.0 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… 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?
- BQ 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- 4 Dec 2021to 16 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- Age 22 to 85 years of age (inclusive).
- Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging.
- 4 to 21 days from stroke onset (or last known well).
- Pre-stroke mRS of 0 or 1.
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- Able to sit with the investigational device for 40 consecutive minutes.
- Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
- Willingness to participate in occupational/physical therapy activities during study intervention sessions.
- Availability of a relative or other caregiver able to assist during PT/OT treatment delivered via video call sessions during the study.
- 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 (if competent) or legally authorized representative.
Who cannot join
- Severe neglect impairment (NIHSS item 11 score = 2) or neglect that is severe enough to interfere with reasonable performance of study procedures. assessments or treatments.
- Implanted active electronic or passive MR-incompatible devices.
- Previous ischemic or hemorrhagic stroke within the 2 weeks before the index stroke.
- 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.
- Significant visual disturbances that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
Show all 12Show fewer
- Unstable serious illness/condition (eg, active cancer, severe heart failure, active psychiatric condition) or life expectancy of less than 6 12 months.
- A known severe allergic reaction to acrylic-based adhesives.
- Ongoing alcohol abuse and/or illicit drug use.
- 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
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
NYP Brooklyn Methodist Hospital Outpatient Rehabilitation
Brooklyn, New York, 11215
Atrium Health Carolinas Rehabilitation
Charlotte, North Carolina, 28203
Shirley Ryan Abilitylab
Chicago, Illinois, 60611
Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246
Rancho Research Institute
Downey, California, 90242
JFK Johnson Rehabilitation Institute
Edison, New Jersey, 08820
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
TIRR Memorial Hermann Hospital
Houston, Texas, 77030
Brooks Rehabilitation Hospital - University Campus
Jacksonville, Florida, 32216
KU Medical Center
Kansas City, Kansas, 66160
Ronald Reagan UCLA Medical Center & California Rehabilitation Institute
Los Angeles, California, 90095
The Miami Project to Cure Paralysis
Miami, Florida, 33136
MedStar National Rehabililtaion Hospital,
Washington D.C., District of Columbia, 20010
Kessler Institute of Rehabilitation
West Orange, New Jersey, 07052
About this study
This is a multicenter study that will be conducted at approximately 20 centers. BQ 2.0 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.
In this study, BQ 2.0 is intended to reduce disability in adult patients with subacute ischemic stroke, with a moderate to severe disability which includes an upper extremity motor impairment.
Read more
BQ 2.0 will be used for 9 weeks in conjunction with physical and occupational therapy (PT/OT) and periodic supervision (either remote or in person) of a trained site study team member. Treatments may be administered in multiple settings (e.g. acute care hospital (ACH) or inpatient rehabilitation facilities (IRF), Skilled Nursing Facility (SNF), home or other outpatient setup).
The study will enroll up to 150 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0.
Read the detailed description
The study intervention will be initiated 4-21 days after the index stroke event and will consist of a total of 45 sessions over a period of 9 weeks (5 treatments per week). Each session will last 60 minutes during which 40 net minutes of active or sham study intervention using BQ 2.0 will be administered. Each study group will receive a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.
Screening phase:
Prospective subjects, who are 3 to 21 days post-stroke, will be consented to participate in the study at either:
- a participating initial acute care hospital (ACH), prior to anticipated transfer to a participating IRF, SNF, Outpatient or home setting or
- at a participating IRF, SNF, outpatient or home setting
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.
Treatment and follow-up Randomized patients will proceed to the treatment phase of the study. Active or sham study intervention sessions using BQ 2.0 (active or sham therapy, respectively) will be conducted 5 times a week, starting 4-21 days after stroke onset and no later than 2 days after randomization. Each session will last 60 minutes, with active or sham field being turned on for up to 40 minutes. The only difference between the BQ 2.0 active stimulation and sham therapy is that the sham device does not generate electromagnetic fields during treatment. Subjects in both the active intervention group (BQ 2.0 group) and sham group will be asked to perform device guided physical and occupational therapy activities during each session. Participation in the study will not replace any of usual care patient should recieve.
Subjects will undergo a detailed interim outcome assessment on the 20th (±4) day of treatment 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.
- Conditions
- Ischemic Stroke
- Being tested
- BQ 2.0
- Keywords
- subacute
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BQ 2.0Device
Also called BQ 2.0 sham stimulation group
frequency and intensity parameters will be set to zero so that no stimulation is delivered
BQ 2.0Device
Also called BQ 2.0 active stimulation group
The BQ 2.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; up to 1 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 2.0 sham stimulation group | Sham comparator | 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. Receives: Device: BQ 2.0 |
| BQ 2.0 active stimulation group | Active comparator | 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. Receives: Device: BQ 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Modified Rankin Scale
Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke)
Measured: change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit
Secondary outcomes (6)
Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function)
Lead secondary endpoint: Fugl-Meyer Assessment for Upper Extremity (upper limb function) - to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
Measured: change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit
Change from Baseline in Box and Block Test (fine hand function)
Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
Measured: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)
Change from Baseline in 10 Meter Walk Test (gait speed)
Secondary Endpoint: To show the BQ therapy is effective in reducing lower limb imperement
Measured: change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )
Change from baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
Measured: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )
Change from baseline in Stroke Impact Scale 16 (patient-reported physical functional limitation)
Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
Measured: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )
Change from baseline in 5-level EQ-5D (health-related quality of life)
Secondary Endpoint: To show that the BQ therapy is effective in improving health-related quality of life (HRQoL)
Measured: Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start4 Dec 2021
- Primary completion6 Nov 2023
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 BQ 2.0
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainQ Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Saver, MD, Principal investigator, Lead Coordinating PIPamela W Duncan, PhD, Principal investigator, Lead Coordinating PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044507
- Sponsor's protocol ID
- BQ5
- Acronym
- BQ5
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Saver JL, Duncan PW, Stein J, Cramer SC, Fox EJ, Zorowitz RD, Billinger SA, Eickmeyer SM, Kirshblum SC, Androwis GJ, Edwards J, Savitz SI, Koch S, Shall MB, Black-Schaffer RM, Bonato P, Cuccurullo SJ, Barcikowski J, Cao N, Bornstein NM; EMAGINE 1 Trial Investigators. Electromagnetic Stimulation to Reduce Disability After Ischemic Stroke: The EMAGINE Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537880. doi: 10.1001/jamanetworkopen.2025.37880.
PubMed 41105410Saver JL, Duncan PW, Stein J, Cramer SC, Eng JJ, Lifshitz A, Hochberg A, Bornstein NM. EMAGINE-Study protocol of a randomized controlled trial for determining the efficacy of a frequency tuned electromagnetic field treatment in facilitating recovery within the subacute phase following ischemic stroke. Front Neurol. 2023 May 5;14:1148074. doi: 10.3389/fneur.2023.1148074. eCollection 2023.
PubMed 37213907
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. 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" STUDY)
- ClinicalTrials.gov ID
- NCT05044507
- Acronym / sponsor ID
- BQ5 / BQ5
- Conditions
- Ischemic Stroke
- Keywords
- subacute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BrainQ Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2021 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 14 Sep 2021 (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. BQ 2.0 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.
In this study, BQ 2.0 is intended to reduce disability in adult patients with subacute ischemic stroke, with a moderate to severe disability which includes an upper extremity motor impairment.
BQ 2.0 will be used for 9 weeks in conjunction with physical and occupational therapy (PT/OT) and periodic supervision (either remote or in person) of a trained site study team member. Treatments may be administered in multiple settings (e.g. acute care hospital (ACH) or inpatient rehabilitation facilities (IRF), Skilled Nursing Facility (SNF), home or other outpatient setup).
The study will enroll up to 150 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0.
Detailed description
The study intervention will be initiated 4-21 days after the index stroke event and will consist of a total of 45 sessions over a period of 9 weeks (5 treatments per week). Each session will last 60 minutes during which 40 net minutes of active or sham study intervention using BQ 2.0 will be administered. Each study group will receive a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.
Screening phase:
Prospective subjects, who are 3 to 21 days post-stroke, will be consented to participate in the study at either:
- a participating initial acute care hospital (ACH), prior to anticipated transfer to a participating IRF, SNF, Outpatient or home setting or
- at a participating IRF, SNF, outpatient or home setting
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.
Treatment and follow-up Randomized patients will proceed to the treatment phase of the study. Active or sham study intervention sessions using BQ 2.0 (active or sham therapy, respectively) will be conducted 5 times a week, starting 4-21 days after stroke onset and no later than 2 days after randomization. Each session will last 60 minutes, with active or sham field being turned on for up to 40 minutes. The only difference between the BQ 2.0 active stimulation and sham therapy is that the sham device does not generate electromagnetic fields during treatment. Subjects in both the active intervention group (BQ 2.0 group) and sham group will be asked to perform device guided physical and occupational therapy activities during each session. Participation in the study will not replace any of usual care patient should recieve.
Subjects will undergo a detailed interim outcome assessment on the 20th (±4) day of treatment 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0
| Arm | Type | Receives |
|---|---|---|
| BQ 2.0 sham stimulation group | Sham comparator | Device: BQ 2.045 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. |
| BQ 2.0 active stimulation group | Active comparator | Device: BQ 2.045 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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- mRS score of 3 or 4.
- FMA-UE score between 10-45 (inclusive) of impaired limb.
- Age 22 to 85 years of age (inclusive).
- Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging.
- 4 to 21 days from stroke onset (or last known well).
Key exclusion criteria (12 listed)
- Severe neglect impairment (NIHSS item 11 score = 2) or neglect that is severe enough to interfere with reasonable performance of study procedures. assessments or treatments.
- Implanted active electronic or passive MR-incompatible devices.
- Previous ischemic or hemorrhagic stroke within the 2 weeks before the index stroke.
- 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.
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 |
|---|---|---|
| BQ 2.0Also: BQ 2.0 sham stimulation groupfrequency and intensity parameters will be set to zero so that no stimulation is delivered | Device | BQ 2.0 active stimulation group, BQ 2.0 sham stimulation group |
| BQ 2.0Also: BQ 2.0 active stimulation groupThe BQ 2.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; up to 1 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery | Device | BQ 2.0 active stimulation group, BQ 2.0 sham stimulation group |
Primary outcome
Change from Baseline in Modified Rankin Scale
Time frame: change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit
Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke)
6 secondary outcomes
Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function)
Time frame: change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit
Change from Baseline in Box and Block Test (fine hand function)
Time frame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)
Change from Baseline in 10 Meter Walk Test (gait speed)
Time frame: change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )
Change from baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
Time frame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )
Change from baseline in Stroke Impact Scale 16 (patient-reported physical functional limitation)
Time frame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )
Change from baseline in 5-level EQ-5D (health-related quality of life)
Time frame: Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 41105410Saver JL, Duncan PW, Stein J, Cramer SC, Fox EJ, Zorowitz RD, Billinger SA, Eickmeyer SM, Kirshblum SC, Androwis GJ, Edwards J, Savitz SI, Koch S, Shall MB, Black-Schaffer RM, Bonato P, Cuccurullo SJ, Barcikowski J, Cao N, Bornstein NM; EMAGINE 1 Trial Investigators. Electromagnetic Stimulation to Reduce Disability After Ischemic Stroke: The EMAGINE Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537880. doi: 10.1001/jamanetworkopen.2025.37880.
- Derived from this study: PubMed 37213907Saver JL, Duncan PW, Stein J, Cramer SC, Eng JJ, Lifshitz A, Hochberg A, Bornstein NM. EMAGINE-Study protocol of a randomized controlled trial for determining the efficacy of a frequency tuned electromagnetic field treatment in facilitating recovery within the subacute phase following ischemic stroke. Front Neurol. 2023 May 5;14:1148074. doi: 10.3389/fneur.2023.1148074. eCollection 2023.
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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. This study is not recruiting at the moment.
Jeffrey L Saver, MD principal investigator
Lead Coordinating PI
Pamela W Duncan, PhD principal investigator
Lead Coordinating PI
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BQ 2.0 in people with Ischemic Stroke, run by BrainQ Technologies Ltd. at 15 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Modified Rankin Scale (time frame: change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05044507, which also lists 2 linked publications.
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 19 Mar 2024.