Efficacy of EMF BCI Based Device on Acute Stroke

BrainQ

Status: Terminated

Conditions: Acute Stroke

Treatments: Device: Sham; Device: BQ

Study type: Interventional

Funder types: Industry

Identifiers

NCT04039178

BQ3

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

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

Treatment:

Device: BQ

Control group

Sham Comparator group

Description:

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

Treatment:

Device: Sham