Efficacy of EMF BCI Based Device on Acute Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients

Conditions
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Acute Stroke

Intervention / Treatment
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* Device: BQ
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, double blinded, sham device controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks. | Device: BQ<br>* 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.<br>* Other names: Formerly VLIFE;|
| Sham Comparator: Control group<br>Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks. | Device: Sham<br>* Sham BQ device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl Meyer Assessment of Upper Extremity (FMA-UE) | FMA score of upper limb, range between 0 to 66 (higher the better) | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARAT | Action Research Arm test | two months | 
| BBT | Box and Blocks test | two months | 
| TMT | Trail making test | two months | 
| NIHSS | The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse. | two months | 
| Promis 10 | The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table | two months | 
| MoCA | Montreal cognitive assessment | two months | 
| mRs | modified Rankin scale, a 0 to 6 scale, the higher the worse | two months | 
| MRI-DTI | magnetic resonance imaging, diffusion tensor imaging | two months | 
| brain recovery biomarkers | UCH-L1, and GFAP | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BCI, BQ, motor function, acute stroke, EMF