Efficacy of EMF BCI Based Device on Acute Stroke

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04039178
• Other study ID #: BQ3
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: March 21, 2020

Study information

• Verified date: February 2021
• Source: BrainQ Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 21, 2020
• Est. primary completion date: March 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

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.
• Sham
Sham BQ device

Locations

Country	Name	City	State
India	BLK super specialty hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
BrainQ Technologies Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment of Upper Extremity (FMA-UE)	FMA score of upper limb, range between 0 to 66 (higher the better)	Two months
Secondary	ARAT	Action Research Arm test	two months
Secondary	BBT	Box and Blocks test	two months
Secondary	TMT	Trail making test	two months
Secondary	NIHSS	The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.	two months
Secondary	Promis 10	The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table	two months
Secondary	MoCA	Montreal cognitive assessment	two months
Secondary	mRs	modified Rankin scale, a 0 to 6 scale, the higher the worse	two months
Secondary	MRI-DTI	magnetic resonance imaging, diffusion tensor imaging	two months
Secondary	brain recovery biomarkers	UCH-L1, and GFAP	two months