The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 30
- 主要终点
- Change from Baseline in Modified Rankin Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a double-blind study, subjects and Investigators will be blinded to the device setting (Active/Sham). The study site team members receiving, storing, dispensing, preparing, and administering the study interventions will be blinded. Subjects' caregivers will also be blinded. There are no differences in the active and sham device appearance. Due to the non-invasive nature of the treatment, as well as the physical characteristic of the EMF, there is no noticeable difference between sessions conducted using an active or a sham device, facilitating full blinding of both subjects and Investigators.
An independent unblinded statistician (not the study statistician) will perform the assessments described. Only the unblinded statistician and members of the DSMB will be exposed to the interim report.
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mRS score of 3 or
- •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
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
BQ 2.0 sham stimulation group
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.
干预措施: BQ 2.0 (Device)
BQ 2.0 active stimulation group
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.
干预措施: BQ 2.0 (Device)
结局指标
主要结局
Change from Baseline in Modified Rankin Scale
时间窗: 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)
次要结局
- Change from Baseline in Box and Block Test (fine hand function)(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)(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 Fugl-Meyer Assessment for Upper Extremity (upper limb function)(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 Stroke Impact Scale Hand Domain (patient-reported hand function)(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 5-level EQ-5D (health-related quality of life)(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 Stroke Impact Scale 16 (patient-reported physical functional limitation)(change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit ))