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The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY) (BQ5)

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BQ 2.0
BQ 2.0
Sponsored by
BrainQ Technologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ischemic Stroke focused on measuring subacute

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ronald Reagan UCLA Medical Center & California Rehabilitation Institute
  • MedStar National Rehabililtaion Hospital,Recruiting
  • Brooks Rehabilitation Hospital - University CampusRecruiting
  • The Miami Project to Cure Paralysis
  • Shirley Ryan AbilitylabRecruiting
  • KU Medical CenterRecruiting
  • Spaulding Rehabilitation HospitalRecruiting
  • JFK Johnson Rehabilitation InstituteRecruiting
  • Kessler Institute of RehabilitationRecruiting
  • NYP Brooklyn Methodist Hospital Outpatient RehabilitationRecruiting
  • Atrium Health Carolinas RehabilitationRecruiting
  • Moss Rehabilitation Research Institute
  • Baylor Scott & White Institute for Rehabilitation
  • TIRR Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

BQ 2.0 sham stimulation group

BQ 2.0 active stimulation group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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 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 in 10 Meter Walk Test (gait speed)
Secondary Endpoint: To show the BQ therapy is effective in reducing lower limb imperement
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 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 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)

Full Information

First Posted
August 4, 2021
Last Updated
February 23, 2023
Sponsor
BrainQ Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05044507
Brief 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)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 4, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BrainQ Technologies Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
subacute

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BQ 2.0 sham stimulation group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
BQ 2.0 active stimulation group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BQ 2.0
Other Intervention Name(s)
BQ 2.0 sham stimulation group
Intervention Description
frequency and intensity parameters will be set to zero so that no stimulation is delivered
Intervention Type
Device
Intervention Name(s)
BQ 2.0
Other Intervention Name(s)
BQ 2.0 active stimulation group
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline in Modified Rankin Scale
Description
Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke)
Time Frame
change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit
Secondary Outcome Measure Information:
Title
Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function)
Description
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
Time Frame
change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit
Title
Change from Baseline in Box and Block Test (fine hand function)
Description
Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
Time Frame
change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)
Title
Change from Baseline in 10 Meter Walk Test (gait speed)
Description
Secondary Endpoint: To show the BQ therapy is effective in reducing lower limb imperement
Time Frame
change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )
Title
Change from baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
Description
Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
Time Frame
change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )
Title
Change from baseline in Stroke Impact Scale 16 (patient-reported physical functional limitation)
Description
Secondary Endpoint: to show that the BQ therapy is effective in reducing upper limb impairment, and improving upper limb functionality
Time Frame
change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )
Title
Change from baseline in 5-level EQ-5D (health-related quality of life)
Description
Secondary Endpoint: To show that the BQ therapy is effective in improving health-related quality of life (HRQoL)
Time Frame
Change from baseline (4-21 days post-stroke) to 90 days post-stroke (will be assessed on 90 Day FU visit )
Other Pre-specified Outcome Measures:
Title
Serious procedure or device related adverse events & device deficiencies
Description
Safety: To characterize the safety profile of the BQ therapy and to show that the BQ 2.0 performs reliably.
Time Frame
Through study completion, an average of 90 ± 15 days post-stroke (will be assessed on 90 Day FU visit )
Title
Change in Montreal Cognitive Assessment (global cognitive function)
Description
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.
Time Frame
will be assessed at 90 Day FU visit
Title
Change in Patient Health Questionnaire-8 (depression)
Description
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.
Time Frame
will be assessed on 90 Day FU visit
Title
Change in Academic Medical Center Linear Disability Scale (granular level of disability) at 90 days post-stroke.
Description
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.
Time Frame
will be assessed on 90 Day FU visit
Title
Change from Baseline in Modified Rankin Scale (global disability)
Description
Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality
Time Frame
change from baseline (4-21 days post-stroke) to 180 days post-stroke. will be assessed at 6 month FU visit
Title
Change from Baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)
Description
Tertiary/Exploratory: To characterize the long-term effect at 6 months post-stroke of the BQ therapy effect on upper limb functionality
Time Frame
change from baseline (4-21 days post-stroke) to 180 days post-stroke will be assessed at 6 month FU visit
Title
Change from Baseline in 5-level EQ-5D (health-related quality of life) at 180 days post-stroke.
Description
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).
Time Frame
change from baseline (4-21 days post-stroke) to 180 days post-stroke (will be assessed at 6 month FU visit )
Title
Formal cost-effectiveness analysis over a lifetime horizon from the perspective of the United States healthcare system.
Description
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.
Time Frame
Will be assessed at 90 day FU visit and 6 month FU visit
Title
adherence to treatment as measured by the Qompass
Description
To explore the relationship between adherence to treatment as measured by the Qompass
Time Frame
Will be assessed upon data base lock

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mRS score of 3 or 4. 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 1. 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. Exclusion Criteria: 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. Prisoner.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Assaf Lifshitz
Phone
972 54 4586787
Email
assaf@brainqtech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Saver, MD
Organizational Affiliation
Lead Coordinating PI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela W Duncan, PhD
Organizational Affiliation
Lead Coordinating PI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center & California Rehabilitation Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilda Avila
Email
GAvila@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Mersedeh Bahr Hosseini, MD
First Name & Middle Initial & Last Name & Degree
Michael Su, MD
Facility Name
MedStar National Rehabililtaion Hospital,
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathaleen Brady
Email
Kathaleen.P.Brady@medstar.net
First Name & Middle Initial & Last Name & Degree
Richard Zorowitz, MD
Facility Name
Brooks Rehabilitation Hospital - University Campus
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah, MS, ACSM-EP
Email
Hannah.Snyder@Brooksrehab.org
First Name & Middle Initial & Last Name & Degree
Emily Fox
Facility Name
The Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iszet Campo-Bustillo
Phone
305-243-8018
Email
icampo@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Ning Cao, MD
Facility Name
Shirley Ryan Abilitylab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara J Prokup, PT, DPT
Email
sprokup@ricres.org
First Name & Middle Initial & Last Name & Degree
Eliot Roth, MD
Facility Name
KU Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasha Moors
Email
smoores@kumc.edu
First Name & Middle Initial & Last Name & Degree
Sandra Billinger, PT, PhD,FAHA
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Min
Email
bq5@partners.org
First Name & Middle Initial & Last Name & Degree
Randie Black-Schaffer, MD
Facility Name
JFK Johnson Rehabilitation Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Belen Montealegre, OTD
Phone
(732) 321-7000
Ext
62853
Email
maria.montealegre@hmhn.org
First Name & Middle Initial & Last Name & Degree
Sara J Cuccurullo, MD
Facility Name
Kessler Institute of Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghaith Androwis, Ph.D.
Phone
973-324-3565
Email
gandrowis@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
Steven Kirshblum, MD
Facility Name
NYP Brooklyn Methodist Hospital Outpatient Rehabilitation
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy J Rutherford
Phone
718-780-7715
Email
jor9147@nyp.org
First Name & Middle Initial & Last Name & Degree
Joel Stein, MD
Facility Name
Atrium Health Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tami Guerrier
Email
Tami.Guerrier@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Matthew Shall, MD
Facility Name
Moss Rehabilitation Research Institute
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Loscalzo
Email
CaoNing1@einstein.edu
First Name & Middle Initial & Last Name & Degree
Ning Chao, MD
Facility Name
Baylor Scott & White Institute for Rehabilitation
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lacy Mcdonald
Email
LACY.MCDONALD@BSWHEALTH.ORG
First Name & Middle Initial & Last Name & Degree
Simon Driver, PhD
Facility Name
TIRR Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Stevens, OTR
Email
Emily.A.Stevens@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sean Savitz, MD

12. IPD Sharing Statement

Learn more about this trial

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

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