- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04039178
Efficacy of EMF BCI Based Device on Acute Stroke
The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Delhi, India
- BLK Super Specialty Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment group
Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks.
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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.
Other Names:
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Sham Comparator: Control group
Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks.
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Sham BQ device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl Meyer Assessment of Upper Extremity (FMA-UE)
Time Frame: Two months
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FMA score of upper limb, range between 0 to 66 (higher the better)
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Two months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ARAT
Time Frame: two months
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Action Research Arm test
|
two months
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BBT
Time Frame: two months
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Box and Blocks test
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two months
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TMT
Time Frame: two months
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Trail making test
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two months
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NIHSS
Time Frame: two months
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The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.
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two months
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Promis 10
Time Frame: two months
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The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table
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two months
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MoCA
Time Frame: two months
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Montreal cognitive assessment
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two months
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mRs
Time Frame: two months
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modified Rankin scale, a 0 to 6 scale, the higher the worse
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two months
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MRI-DTI
Time Frame: two months
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magnetic resonance imaging, diffusion tensor imaging
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two months
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brain recovery biomarkers
Time Frame: two months
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UCH-L1, and GFAP
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two months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dharam P Pandey, PhD, BLK hospital , New Delhi , India
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BQ3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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