Clinical trial NCT05044507: The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" 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" STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: subacute
Lead sponsor: BrainQ Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Modified Rankin Scale
timeFrame: change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit
Secondary outcomes:
measure: Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function)
timeFrame: change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit
measure: Change from Baseline in Box and Block Test (fine hand function)
timeFrame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)
measure: Change from Baseline in 10 Meter Walk Test (gait speed)
timeFrame: change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )
measure: Change from baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
timeFrame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )
measure: Change from baseline in Stroke Impact Scale 16 (patient-reported physical functional limitation)
timeFrame: change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )
measure: Change from baseline in 5-level EQ-5D (health-related quality of life)
timeFrame: Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit )
Other outcomes:
measure: Serious procedure or device related adverse events & device deficiencies
timeFrame: Through study completion, an average of 90 ± 15 days post-stroke (will be assessed on 90 Day FU visit )
measure: Change in Montreal Cognitive Assessment (global cognitive function)
timeFrame: will be assessed at 90 Day FU visit
measure: Change in Patient Health Questionnaire-8 (depression)
timeFrame: will be assessed on 90 Day FU visit
measure: Change in Academic Medical Center Linear Disability Scale (granular level of disability) at 90 days post-stroke.
timeFrame: will be assessed on 90 Day FU visit
measure: Change from Baseline in Modified Rankin Scale (global disability)
timeFrame: change from baseline (4-21 days post-stroke) to 180 days post-stroke. will be assessed at 6 month FU visit
measure: Change from Baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
timeFrame: change from baseline (4-21 days post-stroke) to 180 days post-stroke will be assessed at 6 month FU visit
measure: Change from Baseline in 5-level EQ-5D (health-related quality of life) at 180 days post-stroke.
timeFrame: change from baseline (4-21 days post-stroke) to 180 days post-stroke (will be assessed at 6 month FU visit )
measure: Formal cost-effectiveness analysis over a lifetime horizon from the perspective of the United States healthcare system.
timeFrame: Will be assessed at 90 day FU visit and 6 month FU visit
measure: adherence to treatment as measured by the Qompass
timeFrame: Will be assessed upon data base lock
Locations:
city: Downey
country: United States
facility: Rancho Research Institute
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center & California Rehabilitation Institute
state: California
city: Washington
country: United States
facility: MedStar National Rehabililtaion Hospital,
state: District of Columbia
city: Jacksonville
country: United States
facility: Brooks Rehabilitation Hospital - University Campus
state: Florida
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
city: Chicago
country: United States
facility: Shirley Ryan Abilitylab
state: Illinois
city: Kansas City
country: United States
facility: KU Medical Center
state: Kansas
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Edison
country: United States
facility: JFK Johnson Rehabilitation Institute
state: New Jersey
city: West Orange
country: United States
facility: Kessler Institute of Rehabilitation
state: New Jersey
city: Brooklyn
country: United States
facility: NYP Brooklyn Methodist Hospital Outpatient Rehabilitation
state: New York
city: Charlotte
country: United States
facility: Atrium Health Carolinas Rehabilitation
state: North Carolina
city: Elkins Park
country: United States
facility: Moss Rehabilitation Research Institute
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott & White Institute for Rehabilitation
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: Lead Coordinating PI
name: Jeffrey L Saver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lead Coordinating PI
name: Pamela W Duncan, PhD
role: PRINCIPAL_INVESTIGATOR
References: