Clinical trial NCT04039178: Efficacy of EMF BCI Based Device on Acute Stroke
Official title: The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Stroke
Keywords: BCI
BQ
motor function
acute stroke
EMF
Lead sponsor: BrainQ Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double blinded, sham device controlled study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Fugl Meyer Assessment of Upper Extremity (FMA-UE)
timeFrame: Two months
Secondary outcomes:
measure: ARAT
timeFrame: two months
measure: BBT
timeFrame: two months
measure: TMT
timeFrame: two months
measure: NIHSS
timeFrame: two months
measure: Promis 10
timeFrame: two months
measure: MoCA
timeFrame: two months
measure: mRs
timeFrame: two months
measure: MRI-DTI
timeFrame: two months
measure: brain recovery biomarkers
timeFrame: two months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: BLK super specialty hospital
Study officials:
affiliation: BLK hospital , New Delhi , India
name: Dharam P Pandey, PhD
role: PRINCIPAL_INVESTIGATOR
References: