Acute Stroke
Conditions
Keywords
BCI, BQ, motor function, acute stroke, EMF
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.
Interventions
DEVICEBQ
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.
DEVICESham
Sham BQ device
Sponsors
BrainQ Technologies Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sham device appears as real device. Only randomizer which is a third party, is unblinded. First 4 patients are non randomized
Intervention model description
Prospective, randomized, double blinded, sham device controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. 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). 3. Medically stable patients 4. Age: \> 18, \<80 years, and independent in their daily activities before the stroke 5. Right dominant hand 6. FM \>10, \<45 of upper tested limb. 7. 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 8. Able to understand the information provided and provide informed consent
Exclusion criteria
1. Contraindication for performing MRI scanning 2. History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold 3. Patients with an acute problem such as active infection at the time of recruitment for research 4. Previous disease of the central nervous system 5. Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested 6. Patients known to suffer from some peripheral nerve damage of the upper limb that being tested 7. Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study. 8. Alcoholism or drug addiction as defined by DSM-IV within last 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Assessment of Upper Extremity (FMA-UE) | Two months | FMA score of upper limb, range between 0 to 66 (higher the better) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BBT | two months | Box and Blocks test |
| TMT | two months | Trail making test |
| NIHSS | two months | The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse. |
| Promis 10 | two months | The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table |
| ARAT | two months | Action Research Arm test |
| mRs | two months | modified Rankin scale, a 0 to 6 scale, the higher the worse |
| MRI-DTI | two months | magnetic resonance imaging, diffusion tensor imaging |
| brain recovery biomarkers | two months | UCH-L1, and GFAP |
| MoCA | two months | Montreal cognitive assessment |
Countries
India
Outcome results
None listed