Efficacy of EMF BCI Based Device on Acute Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2020-03-21

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acute Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, double blinded, sham device controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sham device appears as real device. Only randomizer which is a third party, is unblinded. First 4 patients are non randomized

Study Groups

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Treatment group

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

Group Type ACTIVE_COMPARATOR

BQ

Intervention Type 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.

Control group

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

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Sham BQ device

Interventions

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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.

Intervention Type DEVICE

Sham

Sham BQ device

Intervention Type DEVICE

Other Intervention Names

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Formerly VLIFE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No