Efficacy of EMF BCI Based Device on Acute Stroke
- Conditions
- Acute Stroke
- Interventions
- Device: BQDevice: Sham
- Registration Number
- NCT04039178
- Lead Sponsor
- BrainQ Technologies Ltd.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
-
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).
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Medically stable patients
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Age: > 18, <80 years, and independent in their daily activities before the stroke
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Right dominant hand
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FM >10, <45 of upper tested limb.
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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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group BQ Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks. Control group Sham Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks.
- Primary Outcome Measures
Name Time Method Fugl Meyer Assessment of Upper Extremity (FMA-UE) Two months FMA score of upper limb, range between 0 to 66 (higher the better)
- Secondary Outcome Measures
Name Time Method BBT two months Box and Blocks test
TMT two months Trail making test
Promis 10 two months The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table
mRs two months modified Rankin scale, a 0 to 6 scale, the higher the worse
ARAT two months Action Research Arm test
NIHSS two months The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.
MoCA two months Montreal cognitive assessment
MRI-DTI two months magnetic resonance imaging, diffusion tensor imaging
brain recovery biomarkers two months UCH-L1, and GFAP
Trial Locations
- Locations (1)
BLK super specialty hospital
🇮🇳New Delhi, India