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Efficacy of EMF BCI Based Device on Acute Stroke

Sponsor
BrainQ Technologies Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04039178
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
18.5
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: BQ
  • Device: Sham
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, randomized, double blinded, sham device controlled studyProspective, randomized, double blinded, sham device controlled study
Masking:
Quadruple (Participant, Care Provider, 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
Primary Purpose:
Treatment
Official Title:
The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
Actual Study Start Date :
Sep 4, 2018
Actual Primary Completion Date :
Mar 21, 2020
Actual Study Completion Date :
Mar 21, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment group

Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks.

Device: BQ
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.
Other Names:
  • Formerly VLIFE

    		•
    Sham Comparator: Control group

    Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks.

    Device: Sham
    Sham BQ device

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. ARAT [two months]

      Action Research Arm test

    2. BBT [two months]

      Box and Blocks test

    3. TMT [two months]

      Trail making test

    4. NIHSS [two months]

      The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.

    5. Promis 10 [two months]

      The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table

    6. MoCA [two months]

      Montreal cognitive assessment

    7. mRs [two months]

      modified Rankin scale, a 0 to 6 scale, the higher the worse

    8. MRI-DTI [two months]

      magnetic resonance imaging, diffusion tensor imaging

    9. brain recovery biomarkers [two months]

      UCH-L1, and GFAP

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BLK super specialty hospital New Delhi India

    Sponsors and Collaborators

    • BrainQ Technologies Ltd.

    Investigators

    • Principal Investigator: Dharam P Pandey, PhD, BLK hospital , New Delhi , India

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BrainQ Technologies Ltd.
    ClinicalTrials.gov Identifier:
    NCT04039178
    Other Study ID Numbers:
    • BQ3
    First Posted:
    Jul 31, 2019
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by BrainQ Technologies Ltd.
    BCI
    BQ
    motor function
    acute stroke
    EMF
    Additional relevant MeSH terms:
    Stroke

    Study Results

    No Results Posted as of Feb 11, 2021