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

Ischemic Stroke Clinical Trial

— BQ5  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05044507
• Other study ID #: BQ5
• Status: Completed
• Phase: N/A
• Start date: December 4, 2021
• Est. completion date: January 16, 2024

Study information

• Verified date: February 2024
• Source: BrainQ Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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:

1. a participating initial acute care hospital (ACH), prior to anticipated transfer to a participating IRF, SNF, Outpatient or home setting or

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 16, 2024
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

Inclusion Criteria:

1. mRS score of 3 or 4.

2. FMA-UE score between 10-45 (inclusive) of impaired limb.

3. Age 22 to 85 years of age (inclusive).

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

5. 4 to 21 days from stroke onset (or last known well).

6. Pre-stroke mRS of 0 or 1.

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

8. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".

9. Willingness to participate in occupational/physical therapy activities during study intervention sessions.

10. Availability of a relative or other caregiver able to assist during PT/OT treatment delivered via video call sessions during the study.

11. 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

12. Informed consent signed by subject (if competent) or legally authorized representative.

Exclusion Criteria:

1. 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.

2. Implanted active electronic or passive MR-incompatible devices.

3. Previous ischemic or hemorrhagic stroke within the 2 weeks before the index stroke.

4. 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.

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

6. 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.

7. Unstable serious illness/condition (eg, active cancer, severe heart failure, active psychiatric condition) or life expectancy of less than 6 12 months.

8. A known severe allergic reaction to acrylic-based adhesives.

9. Ongoing alcohol abuse and/or illicit drug use.

10. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.

11. Employee of the Sponsor.

12. Prisoner.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• BQ 2.0
frequency and intensity parameters will be set to zero so that no stimulation is delivered
• BQ 2.0
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

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts
United States	NYP Brooklyn Methodist Hospital Outpatient Rehabilitation	Brooklyn	New York
United States	Atrium Health Carolinas Rehabilitation	Charlotte	North Carolina
United States	Shirley Ryan Abilitylab	Chicago	Illinois
United States	Baylor Scott & White Institute for Rehabilitation	Dallas	Texas
United States	Rancho Research Institute	Downey	California
United States	JFK Johnson Rehabilitation Institute	Edison	New Jersey
United States	Moss Rehabilitation Research Institute	Elkins Park	Pennsylvania
United States	TIRR Memorial Hermann Hospital	Houston	Texas
United States	Brooks Rehabilitation Hospital - University Campus	Jacksonville	Florida
United States	KU Medical Center	Kansas City	Kansas
United States	Ronald Reagan UCLA Medical Center & California Rehabilitation Institute	Los Angeles	California
United States	The Miami Project to Cure Paralysis	Miami	Florida
United States	MedStar National Rehabililtaion Hospital,	Washington	District of Columbia
United States	Kessler Institute of Rehabilitation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
BrainQ Technologies Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serious procedure or device related adverse events & device deficiencies	Safety: To characterize the safety profile of the BQ therapy and to show that the BQ 2.0 performs reliably.	Through study completion, an average of 90 ± 15 days post-stroke (will be assessed on 90 Day FU visit )
Other	Change in Montreal Cognitive Assessment (global cognitive function)	Tertiary/Exploratory: To show that the BQ therapy is effective in reducing cognitive impairment at 3 months post-stroke, when initiated 4 to 14 days following an ischemic stroke.	will be assessed at 90 Day FU visit
Other	Change in Patient Health Questionnaire-8 (depression)	Tertiary/Exploratory: To show that the BQ therapy is effective in reducing depression at 3 months post-stroke, when initiated 4 to 14 days following an ischemic stroke.	will be assessed on 90 Day FU visit
Other	Change in Academic Medical Center Linear Disability Scale (granular level of disability) at 90 days post-stroke.	Tertiary/Exploratory: To show that the BQ therapy is effective in reducing fine-grained level of disability at 3 months post-stroke, when initiated 4 to 14 days following an ischemic stroke.	will be assessed on 90 Day FU visit
Other	Change from Baseline in Modified Rankin Scale (global disability)	Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality	change from baseline (4-21 days post-stroke) to 180 days post-stroke. will be assessed at 6 month FU visit
Other	Change from Baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)	Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality	change from baseline (4-21 days post-stroke) to 180 days post-stroke will be assessed at 6 month FU visit
Other	Change from Baseline in 5-level EQ-5D (health-related quality of life) at 180 days post-stroke.	Tertiary/Exploratory:To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on health-related quality of life (HRQoL).	change from baseline (4-21 days post-stroke) to 180 days post-stroke (will be assessed at 6 month FU visit )
Other	Formal cost-effectiveness analysis over a lifetime horizon from the perspective of the United States healthcare system.	Tertiary/Exploratory: To formally evaluate the cost-effectiveness of the BQ therapy over a lifetime horizon from the perspective of the United States healthcare system.	Will be assessed at 90 day FU visit and 6 month FU visit
Other	adherence to treatment as measured by the Qompass	To explore the relationship between adherence to treatment as measured by the Qompass	Will be assessed upon data base lock
Primary	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)	change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit
Secondary	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	change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit
Secondary	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	change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)
Secondary	Change from Baseline in 10 Meter Walk Test (gait speed)	Secondary Endpoint: To show the BQ therapy is effective in reducing lower limb imperement	change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )
Secondary	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	change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )
Secondary	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	change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )
Secondary	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)	Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit )