EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

Ischemic Stroke Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386874
• Other study ID #: BQ7
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: October 2026

Study information

• Verified date: June 2024
• Source: BrainQ Technologies Ltd.
• Contact: Assaf Lifshitz
• Phone: 9720544586787
• Email: assaf[@]brainqtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter study that will be conducted at approximately 15 centers.

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 BQ 3.0 system is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies. Up to 45 sessions between days 4 and 90 (±15) after the onset of the index stroke, with up to 5 treatments per week. Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program.

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 3.0 system

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 3.0 will be administered in conjunction with a home-based exercise program.

Screening phase:

Prospective subjects, who are 3 to 21 days post-stroke, may be offered informed consent to participate in the study at either:

1. a participating inpatient or outpatient center,

2. non-participating inpatient or outpatient center, in accordance with both the participating and the non-participating centers' policy, or

3. 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 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 (and any blinded personnel), will be set to zero so that no stimulation is delivered.

Treatment Phase:

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 a total of 45 sessions over a period of 9 weeks (5 treatments per week). Missed sessions may be made up until the primary endpoint follow-up visit, at day 90 (±15) after the onset of the index stroke Each 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 will 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: October 2026
• Est. primary completion date: July 2026
• 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. SAFE score >0.

4. Age 22 to 80 years of age (inclusive).

5. Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.

6. 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.

7. Four to 21 days from stroke onset (or last known well).

8. Pre-stroke mRS of 0.

9. Able to sit with the investigational device for 40 consecutive minutes, in the opinion of the investigator or designee.

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

11. Willingness to participate in an exercise activity during study intervention sessions.

12. 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.

13. 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

14. Informed consent signed by subject.

Exclusion Criteria:

1. Hemineglect impairment (NIHSS item 11, score >0).

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

3. 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.

4. 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

5. 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.

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

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

8. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.

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

10. Employee of the Sponsor.

11. Prisoner.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• BQ 3.0 system
frequency and intensity parameters will be set to zero so that no stimulation is delivered
• BQ 3.0
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	MedStar National Rehabililtaion Hospital,	Washington	District of Columbia

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	To characterize the safety profile of the BQ therapy and to show that the BQ 3.0 performs reliably.	Through study completion, an average of 90 ± 15 days post-stroke
Other	Change in Montreal Cognitive Assessment (global cognitive function)	To show that the BQ therapy is effective in reducing cognitive impairment, at 3 months post-stroke, when initiated 4 to 21 days following an ischemic stroke.	at 90-day post-stroke
Other	Change in Patient Health Questionnaire-8 (depression)	To show that the BQ therapy is effective in reducing depression, at 3 months post-stroke, when initiated 4 to 21 days following an ischemic stroke.	at 90-day post stroke
Other	Academic Medical Center Linear Disability Scale (granular level of disability)	To show that the BQ therapy is effective in reducing fine-grained level of disability at 3 months post-stroke	At 90-day and 180 days post stroke
Other	Proportion of subjects achieving freedom from disability (modified Rankin Scale score of 0-1)	To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on global disability	at 180 days post-stroke.
Other	Stroke Impact Scale Hand Domain (patient-reported hand function) - change from baseline (4-21 days post-stroke) to 180 days post-stroke.	To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb function	4 to 21 days following an ischemic stroke to 180-day post-stroke
Other	Stroke Impact Scale 16 (patient-reported physical functional limitation)	o characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb function	4 to 21 days following an ischemic stroke to 180-day post-stroke
Other	5-level EQ-5D (health-related quality of life)	To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on health-related quality of life (HRQoL).	at 180 days post-stroke.
Other	Formal cost-effectiveness analysis over a lifetime horizon from the perspective of the United States healthcare system.	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 MidTerm (45 Day ± 4 days post- stroke) , Day-90 and D-180 post stroke
Other	Zarit Burden Interview	To formally evaluate the cost-effectiveness of the BQ therapy via caregiver burden.	Will be assessed at midterm (45 Day ± 4 days post- stroke) , 90 days and 180 days post-stroke
Other	Relationship between adherence to treatment as measured by the Qompass and the clinical outcomes.	To explore the relationship between adherence to treatment as measured by the Qompass and clinical outcomes.	Will be assessed upon data base lock
Primary	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.	4 to 21 days following an ischemic stroke to 90-day post-stroke
Secondary	Change from Baseline in Modified Rankin Scale (Lead secondary endpoint)	Proportion of subjects achieving functional independence (modified Rankin Scale score of 0-2) at the 90- day post-stroke assessment.	4 to 21 days following an ischemic stroke to 90-day post-stroke
Secondary	Change from Baseline in Modified Rankin Scale	Proportion of subjects achieving functional independence - To show that the BQ therapy is effective in achieving functional independency	4 to 21 days following an ischemic stroke to MidTerm ( 45 Day ± 4 days post- stroke) assessment
Secondary	Change from Baseline in Stroke Impact Scale Hand Domain	Patient reported hand function - To show that the BQ therapy is effective in reducing upper limb impairment and improving upper limb function	4 to 21 days following an ischemic stroke to 90-day post-stroke
Secondary	Change in Baseline in Stroke Impact Scale 16	Patient-reported physical functional limitation - To show that the BQ therapy is effective in improving physical functional limitation	4 to 21 days following an ischemic stroke to 90-day post-stroke
Secondary	Change from baseline in Box and Block Test	Arm motor function - To show that the BQ therapy is effective in improving Arm motor function	4 to 21 days following an ischemic stroke to 90-day post-stroke
Secondary	Change in baseline in Fugl-Meyer Assessment for Upper Extremity	FMA-UE; upper limb function - To show that the BQ therapy is effective in achieving reducing upper limb impairment, and improving upper limb function	4 to 21 days following an ischemic stroke to 90-day post-stroke
Secondary	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)	At 90-days post-stroke
Secondary	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	At 90-days post-stroke
Secondary	Change in 10-meter Walk Test	The Functional Ambulation Categories (FAC) will be collected concurrent to the 10MWT to assess the level of independent ambulation.	At 90-days post-stroke