Efficacy of EMF BCI Based Device on Acute Stroke

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: Acute Stroke
• Intervention / Treatment: Device: BQ; Device: Sham

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

Study Locations

• India
  • New Delhi, India
    • BLK Super Specialty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARAT	Action Research Arm test	two months
BBT	Box and Blocks test	two months
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

Collaborators and Investigators

• Sponsor: BrainQ Technologies Ltd.
• Investigators: Principal Investigator: Dharam P Pandey, PhD, BLK hospital , New Delhi , India

Study record dates

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

• Keywords: motor function; acute stroke; BCI; BQ; EMF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: BQ3

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