Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386874
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-16
Brief Title:
EMAGINE 20 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment
Sponsor:
BrainQ Technologies Ltd
Organization:
BrainQ Technologies Ltd
Study Overview
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 20 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
Yes
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter study that will be conducted at approximately 15 centers
BQ 30 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 30 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 11 allocation ratio to either active or sham study intervention using BQ 30 system
BQ 30 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 30 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 11 allocation ratio to either active or sham study intervention using BQ 30 system
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 30 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 11 allocation ratio to either the active or sham study intervention groups
Stimulation with BQ 30 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 ie 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 sponsors 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 subjects participation in the trial will be recorded
Participation in the study will not replace any of the usual care patient should receive
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 11 allocation ratio to either the active or sham study intervention groups
Stimulation with BQ 30 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 ie 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 sponsors 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 subjects participation in the trial will be recorded
Participation in the study will not replace any of the usual care patient should receive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None