Back to resultsEfficacy of EMF BCI Based Device on Acute Stroke
Primary Purpose
Acute Stroke
Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
BQ
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring BCI, BQ, motor function, acute stroke, EMF
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of 1st ever ischemic stroke confirmed by imaging or 1st recurrent ischemic stroke with no previous neurological impairment in the same limb before current stroke happened
- 72h to 15 days from stroke onset or 21 days from stroke onset in case the patient was still unstable at day 15 from stroke onset).
- Medically stable patients
- Age: > 18, <80 years, and independent in their daily activities before the stroke
- Right dominant hand
- FM >10, <45 of upper tested limb.
Able to sit in a chair for 70 consecutive minutes and follow three verbal instructions:
- Bring your healthy arm to the level of your shoulder
- Pick up this pen with your healthy hand.
- Put your healthy hand on your waist
- Able to understand the information provided and provide informed consent
Exclusion Criteria
- Contraindication for performing MRI scanning
- History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold
- Patients with an acute problem such as active infection at the time of recruitment for research
- Previous disease of the central nervous system
- Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested
- Patients known to suffer from some peripheral nerve damage of the upper limb that being tested
- Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
- Alcoholism or drug addiction as defined by DSM-IV within last 5 years
Sites / Locations
- BLK super specialty hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Treatment group
Control group
Arm Description
Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks.
Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks.
Outcomes
Primary Outcome Measures
Fugl Meyer Assessment of Upper Extremity (FMA-UE)
FMA score of upper limb, range between 0 to 66 (higher the better)
Secondary Outcome Measures
ARAT
Action Research Arm test
BBT
Box and Blocks test
TMT
Trail making test
NIHSS
The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.
Promis 10
The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table
MoCA
Montreal cognitive assessment
mRs
modified Rankin scale, a 0 to 6 scale, the higher the worse
MRI-DTI
magnetic resonance imaging, diffusion tensor imaging
brain recovery biomarkers
UCH-L1, and GFAP
Full Information
NCT ID
NCT04039178
First Posted
July 29, 2019
Last Updated
February 9, 2021
Sponsor
BrainQ Technologies Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04039178
Brief Title
Efficacy of EMF BCI Based Device on Acute Stroke
Official Title
The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated at the interim point due to the covid-19 pandemic, which did not allow completing full recruitment in relevant timelines
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
March 21, 2020 (Actual)
Study Completion Date
March 21, 2020 (Actual)
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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study tests the efficacy of a non-invasive device with low intensity electromagnetic field dedicated treatment to enhance the recovery of stroke patients impaired hand motor function
Detailed Description
The study investigates the effect of BCI based stimulation device on upper limb motor function of acute stroke patients.
The BQ device (BrainQ Technologies Ltd., Israel), a Brain Computer Interface based stimulation device, uses machine learning tools to identify high resolution spectral patterns associated with motor functions in EEG measurements of healthy/non healthy subjects. These patterns are then translated into a tailored frequency dependent low intensity, non-invasive electro-magnetic treatment protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
BCI, BQ, motor function, acute stroke, EMF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double blinded, sham device controlled study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sham device appears as real device. Only randomizer which is a third party, is unblinded. First 4 patients are non randomized
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks.
Intervention Type
Device
Intervention Name(s)
BQ
Other Intervention Name(s)
Formerly VLIFE
Intervention Description
The BQ device (BrainQ Technologies Ltd., Israel), a Brain Computer Interface based stimulation device, uses machine learning tools to identify high resolution spectral patterns associated with motor functions in EEG measurements of healthy/non healthy subjects. These patterns are then translated into a tailored frequency dependent low intensity, non-invasive electro-magnetic treatment protocol.
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
Sham BQ device
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment of Upper Extremity (FMA-UE)
Description
FMA score of upper limb, range between 0 to 66 (higher the better)
Time Frame
Two months
Secondary Outcome Measure Information:
Title
ARAT
Description
Action Research Arm test
Time Frame
two months
Title
BBT
Description
Box and Blocks test
Time Frame
two months
Title
TMT
Description
Trail making test
Time Frame
two months
Title
NIHSS
Description
The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.
Time Frame
two months
Title
Promis 10
Description
The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table
Time Frame
two months
Title
MoCA
Description
Montreal cognitive assessment
Time Frame
two months
Title
mRs
Description
modified Rankin scale, a 0 to 6 scale, the higher the worse
Time Frame
two months
Title
MRI-DTI
Description
magnetic resonance imaging, diffusion tensor imaging
Time Frame
two months
Title
brain recovery biomarkers
Description
UCH-L1, and GFAP
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of 1st ever ischemic stroke confirmed by imaging or 1st recurrent ischemic stroke with no previous neurological impairment in the same limb before current stroke happened
72h to 15 days from stroke onset or 21 days from stroke onset in case the patient was still unstable at day 15 from stroke onset).
Medically stable patients
Age: > 18, <80 years, and independent in their daily activities before the stroke
Right dominant hand
FM >10, <45 of upper tested limb.
Able to sit in a chair for 70 consecutive minutes and follow three verbal instructions:
Bring your healthy arm to the level of your shoulder
Pick up this pen with your healthy hand.
Put your healthy hand on your waist
Able to understand the information provided and provide informed consent
Exclusion Criteria
Contraindication for performing MRI scanning
History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold
Patients with an acute problem such as active infection at the time of recruitment for research
Previous disease of the central nervous system
Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested
Patients known to suffer from some peripheral nerve damage of the upper limb that being tested
Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
Alcoholism or drug addiction as defined by DSM-IV within last 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dharam P Pandey, PhD
Organizational Affiliation
BLK hospital , New Delhi , India
Official's Role
Principal Investigator
Facility Information:
Facility Name
BLK super specialty hospital
City
New Delhi
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of EMF BCI Based Device on Acute Stroke
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