Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of EMF BCI Based Device on Acute Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039178
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Stroke Device: BQ Device: Sham Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, double blinded, sham device controlled study
Masking: Triple (Participant, 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 : September 4, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Fugle Meyer (FM) [ Time Frame: two months ]
    FM score of upper limb


Secondary Outcome Measures :
  1. ARAT [ Time Frame: two months ]
    Action Research Arm test

  2. BBT [ Time Frame: two months ]
    Box and Blocks test

  3. TMT [ Time Frame: two months ]
    Trail making test

  4. NIHSS [ Time Frame: two months ]
    The national institutes of health stroke scale

  5. Promis 10 [ Time Frame: two months ]
    The PROMIS Global Health short form

  6. MoCA [ Time Frame: two months ]
    Montreal cognitive assessment

  7. mRs [ Time Frame: two months ]
    modified Rankin scale

  8. MRI-DTI [ Time Frame: two months ]
    magnetic resonance imaging, diffusion tensor imaging

  9. brain recovery biomarkers [ Time Frame: two months ]
    UCH-L1, and GFAP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039178


Contacts
Layout table for location contacts
Contact: Dharam P Pandey, PhD +91-9818910029 drdprehab@gmail.com

Locations
Layout table for location information
India
BLK super specialty hospital Recruiting
New Delhi, India
Contact: Dharam P Pandey, PhD    +91-9818910029    dharam.pandey@blkhospital.com   
Principal Investigator: Dharam P Pandey, PhD         
Sub-Investigator: Atul Prasad, MD         
Sponsors and Collaborators
BrainQ Technologies Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Dharam P Pandey, PhD BLK hospital , New Delhi , India
Layout table for additonal information
Responsible Party: BrainQ Technologies Ltd.
ClinicalTrials.gov Identifier: NCT04039178    
Other Study ID Numbers: BQ3
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases