Acute StrokeNCT04039178
Efficacy of EMF BCI Based Device on Acute Stroke
A study testing BQ in people with Acute Stroke, run by BrainQ Technologies Ltd. at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- BQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- 4 Sep 2018to 21 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
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
Read the 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.
- Conditions
- Acute Stroke
- Being tested
- BQ, Sham
- Keywords
- BCI, BQ, motor function, acute stroke, EMF
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BQDevice
Also called Formerly VLIFE
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.
ShamDevice
Sham BQ device
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks. Receives: Device: BQ |
| Control group | Sham comparator | Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment of Upper Extremity (FMA-UE)
FMA score of upper limb, range between 0 to 66 (higher the better)
Measured: Two months
Secondary outcomes (9)
ARAT
Action Research Arm test
Measured: two months
BBT
Box and Blocks test
Measured: two months
TMT
Trail making test
Measured: two months
NIHSS
The national institutes of health stroke scale, a 0 to 42 scale, the higher the worse.
Measured: two months
Promis 10
The PROMIS Global Health short form, 10 questions questionnaire, calculated through a look up t-score table
Measured: two months
MoCA
Montreal cognitive assessment
Measured: two months
mRs
modified Rankin scale, a 0 to 6 scale, the higher the worse
Measured: two months
MRI-DTI
magnetic resonance imaging, diffusion tensor imaging
Measured: two months
brain recovery biomarkers
UCH-L1, and GFAP
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start4 Sep 2018
- Primary completion21 Mar 2020
- Study completion21 Mar 2020
Why it stopped: The study was terminated at the interim point due to the covid-19 pandemic, which did not allow completing full recruitment in relevant timelines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double blinded, sham device controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainQ Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dharam P Pandey, PhD, Principal investigator, BLK hospital , New Delhi , India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039178
- Sponsor's protocol ID
- BQ3
- Status last verified
- Feb 2021
- First submitted
- 29 Jul 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weisinger B, Pandey DP, Saver JL, Hochberg A, Bitton A, Doniger GM, Lifshitz A, Vardi O, Shohami E, Segal Y, Reznik Balter S, Djemal Kay Y, Alter A, Prasad A, Bornstein NM. Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial. Front Neurol. 2022 Nov 14;13:1004677. doi: 10.3389/fneur.2022.1004677. eCollection 2022.
PubMed 36452175
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of ElectroMagnetic Field Brain Computer Interface Based Device in the Management of Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT04039178
- Acronym / sponsor ID
- BQ3
- Conditions
- Acute Stroke
- Keywords
- BCI, BQ, motor function, acute stroke, EMF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated at the interim point due to the covid-19 pandemic, which did not allow completing full recruitment in relevant timelines
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BrainQ Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 21 Mar 2020 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blinded, sham device controlled study
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: BQReal BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks. |
| Control group | Sham comparator | Device: ShamSham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BQAlso: Formerly VLIFEThe 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. | Device | Treatment group |
| ShamSham BQ device | Device | Control group |
Primary outcome
Fugl Meyer Assessment of Upper Extremity (FMA-UE)
Time frame: Two months
FMA score of upper limb, range between 0 to 66 (higher the better)
9 secondary outcomes
ARAT
Time frame: two months
BBT
Time frame: two months
TMT
Time frame: two months
NIHSS
Time frame: two months
Promis 10
Time frame: two months
MoCA
Time frame: two months
mRs
Time frame: two months
MRI-DTI
Time frame: two months
brain recovery biomarkers
Time frame: two months
Results and safety
The study was stopped early (reason given: The study was terminated at the interim point due to the covid-19 pandemic, which did not allow completing full recruitment in relevant timelines). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 36452175Weisinger B, Pandey DP, Saver JL, Hochberg A, Bitton A, Doniger GM, Lifshitz A, Vardi O, Shohami E, Segal Y, Reznik Balter S, Djemal Kay Y, Alter A, Prasad A, Bornstein NM. Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial. Front Neurol. 2022 Nov 14;13:1004677. doi: 10.3389/fneur.2022.1004677. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dharam P Pandey, PhD principal investigator
BLK hospital , New Delhi , India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BQ in people with Acute Stroke, run by BrainQ Technologies Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated at the interim point due to the covid-19 pandemic, which did not allow completing full recruitment in relevant timelines). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assessment of Upper Extremity (FMA-UE) (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.