Health Condition 1: I678- Other specified cerebrovascular diseases
Conditions
Interventions
Intervention1: BQ device (BrainQ Technologies Ltd., Israel): a Brain Computer
Interface based stimulation device, uses machine learning tools to identify high
resolution spectral patterns associated
Sponsors
BrainQ Technologies
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of 1st ever ischemic stroke confirmed by imaging 2. 72h to 15 days from stroke onset. 3. Medically stable patients 4. Age: greater than 18, less than 80 years, and independent in their daily activities before the stroke 5. Right dominant hand 6. FM greater than 10, less than 35 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
Exclusion criteria: 1. Previous stroke 2. Contraindication for performing MRI scanning 3. History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold 4. Patients with an acute problem such as active infection at the time of recruitment for research 5. Previous disease of the central nervous system 6. Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested 7. Patients known to suffer from some peripheral nerve damage of the upper limb that being tested 8. Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study. 9. Alcoholism or drug addiction as defined by DSM-IV within last 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoints: 1. Treatment emergence of adverse events (AEâ??s) Primary Efficacy Endpoints: 1. Significant increase in the Fugl Meyer (FM) score of upper limb treated patients compared with control patients who receive sham treatment. FM test, will be administered Timepoint: 1. Throughout the study 1. At baseline, 30, 60 &90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Box & Blocks Test(BBT) will be administeredTimepoint: Every 2 weeks;FM lower limb, Action Research Arm Test (ARAT), Trail Making Test (TMT), The National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale, PROMIS 10, Montreal Cognitive Assessment test (MoCA), Biomarkers for brain recovery, Functional and DTI Magnetic resonance imaging (MRI) scans will be administered Timepoint: At baseline and week 9 visit;Video recording of some of the tests and Physical Therapy (PT)Timepoint: During treatment sessions | — |
Countries
India
Contacts
Public ContactDr Shariq Anwar
JSS Medical Research India Private Limited
Outcome results
None listed