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The study was terminated at the interim point due to the covid-19 pandemic, which did not allow completing full recruitment in relevant timelines
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks. |
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| Control group | Sham Comparator | Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BQ | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ARAT | Action Research Arm test | two months |
| BBT | Box and Blocks test | two months |
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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:
Able to understand the information provided and provide informed consent
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dharam P Pandey, PhD | BLK hospital , New Delhi , India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BLK super specialty hospital | New Delhi | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36452175 | Derived | Weisinger B, Pandey DP, Saver JL, Hochberg A, Bitton A, Doniger GM, Lifshitz A, Vardi O, Shohami E, Segal Y, Reznik Balter S, Djemal Kay Y, Alter A, Prasad A, Bornstein NM. Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial. Front Neurol. 2022 Nov 14;13:1004677. doi: 10.3389/fneur.2022.1004677. eCollection 2022. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Prospective, randomized, double blinded, sham device controlled study
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Sham device appears as real device. Only randomizer which is a third party, is unblinded. First 4 patients are non randomized
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| Sham | Device | Sham BQ device |
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |