Status:
TERMINATED
Efficacy of EMF BCI Based Device on Acute Stroke
Lead Sponsor:
BrainQ Technologies Ltd.
Conditions:
Acute Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- 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).
- Medically stable patients
- Age: \> 18, \<80 years, and independent in their daily activities before the stroke
- Right dominant hand
- FM \>10, \<45 of upper tested limb.
- 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
- Able to understand the information provided and provide informed consent
- Exclusion Criteria
- Contraindication for performing MRI scanning
- History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold
- Patients with an acute problem such as active infection at the time of recruitment for research
- Previous disease of the central nervous system
- Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested
- Patients known to suffer from some peripheral nerve damage of the upper limb that being tested
- Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
- Alcoholism or drug addiction as defined by DSM-IV within last 5 years
Exclusion
Key Trial Info
Start Date :
September 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04039178
Start Date
September 4 2018
End Date
March 21 2020
Last Update
February 11 2021
Active Locations (1)
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1
BLK super specialty hospital
New Delhi, India