The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Stroke
- Sponsor
- BrainQ Technologies Ltd.
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Fugl Meyer Assessment of Upper Extremity (FMA-UE)
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Fugl Meyer Assessment of Upper Extremity (FMA-UE)
Time Frame: Two months
FMA score of upper limb, range between 0 to 66 (higher the better)
Secondary Outcomes
- TMT(two months)
- BBT(two months)
- Promis 10(two months)
- mRs(two months)
- ARAT(two months)
- NIHSS(two months)
- MoCA(two months)
- MRI-DTI(two months)
- brain recovery biomarkers(two months)