Efficacy of EMF BCI Based Device on Acute Stroke

Not Applicable

Terminated

• Conditions: Acute Stroke

• Registration Number: NCT04039178
• Lead Sponsor: BrainQ Technologies Ltd.

Brief 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

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 Timeline

• Study Start: 2018-09-04
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Primary Completion: 2020-03-21
• Study Completion: 2020-03-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Assessment of Upper Extremity (FMA-UE)	Two months	FMA score of upper limb, range between 0 to 66 (higher the better)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

BLK super specialty hospital; 🇮🇳 New Delhi, India