Efficacy of EMF BCI Based Device on Acute Stroke

February 9, 2021 updated by: BrainQ Technologies Ltd.

The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • New Delhi, India
        • BLK Super Specialty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment group
Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks.
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.
Sham BQ device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ARAT
Time Frame: two months
Action Research Arm test
two months
BBT
Time Frame: two months
Box and Blocks test
two months
TMT
Time Frame: two months
Trail making test
two months
NIHSS
Time Frame: two months
The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.
two months
Promis 10
Time Frame: two months
The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table
two months
MoCA
Time Frame: two months
Montreal cognitive assessment
two months
mRs
Time Frame: two months
modified Rankin scale, a 0 to 6 scale, the higher the worse
two months
MRI-DTI
Time Frame: two months
magnetic resonance imaging, diffusion tensor imaging
two months
brain recovery biomarkers
Time Frame: two months
UCH-L1, and GFAP
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2018

Primary Completion (Actual)

March 21, 2020

Study Completion (Actual)

March 21, 2020

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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