StrokeNCT03994042
Mental Imagery Neurofeedback in Strokerehabilitation
A study testing Mental imagery neurofeedback training in people with Stroke and Hemiparesis, run by Mälardalen University at 3 sites in Sweden.
Trial summary
This research project will investigate neurofeedback training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Mental imagery neurofeedback training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesSweden
- Study dates
- 5 Aug 2019to 17 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 6 months since first time stroke onset and with remaining hemiparesis in upper extremity;
- able to participate fully in the intervention including screening of cognitive function with the Cambridge Neuropsychological Test Automated Battery;
- able to perform Functional Magnetic Resonance Imaging (fMRI);
- able to passively extend the wrist 15 degrees and extend fingers fully with a neutral position of the wrist.
- Subgroup 1 (n=2):
- be able to voluntarily control the power of their grip when requested according to the Visuomotor force tracking method and/or according to the clinical assessment of a therapist (while holding the patient´s hand).
Show all 9Show fewer
- Fugl-Meyer Upper Extremity (UE) scale (Fugl-Meyer 1975): <14 points on the hand subscale (C) in addition to < 48 points on the total score (equivalent to moderate disability in the upper extremity
- Subgroup 2 (n=2):
- no detected voluntary grip or release function
Who cannot join
- Other neurological or musculoskeletal disease/injury, contagious disease or treatment with botulinum toxin in the upper extremity during the past 3 months.
- current or history of epilepsy, hearing problems, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal, infusion device.
- other neurological disorder, pregnancy, current or history of severe psychiatric disorder with need for pharmacological treatment
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Stockholn University Brain Imaging C entre
Stockholm, 11418
Department of rehabilitation medicine at Danderyd University
Stockholm, 18288
Mälardalen University
Västerås, 72123
About this study
Official title: EEG-based Mental Imagery Feedback in Stroke Patients With Severe Hand Dysfunction
This research project will investigate neurofeedback training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). The investigators hypothesize that the feedback training allows to internally stimulate brain motor networks in order to promote functional recovery of the hand.
Read the detailed description
This study will be carried out as a pilot study in order to optimize and set parameters for a subsequent study that will involve more stroke patients. Stroke patients will be trained to mentally imagine the opening and closing of the hand (hereafter named MI, Motor Imagery). During the training, the patients will receive visual feedback in real time that reflects the neural activity related to motor processes. The NeuroFeedback (NF) will be projected with minimal time delay to maximize the neural learning. This type of brain training with feedback is thought to have significant importance to stimulate the ability of the brain to reorganize and compensate for a damaged region.
Each participant will go through the following data collection procedure (total of 27-28 measurement sessions per RP):
- Clinical baseline evaluations, 1 time/week during 3 weeks
- 1 MRI measurement during one week
- 2-3 calibration EEG recordings during one week
- MI-neurofeedback training [3 times/week] + Clinical intervention evaluation [1 time/week] during 4 weeks
- 1 MRI measurement + 1 calibration EEG recording during one week
- Clinical intervention evaluations, 1 time/week during 3 weeks
Magnetic Resonance Imaging (MRI) measurements. The MRI exam will be carried out on a Siemens MAGNETOM Prisma 3T scanner (head-coil with 20 channels) at baseline and at final assessment session at Stockholm University Brain Imaging Centre. The MRI protocol comprises i) anatomical whole brain spin-echo T1 and T2 weighted sequences for description of lesion size and location ii) acquisition of T2*-weighted gradient echo EPI-BOLD images of the whole brain for assessment of resting state functional connectivity of sensorimotor networks (resting-state functional MRI (fMRI)), and iii) the same sequence as the previous with rest interleaved by a motor imagery paradigm further described below.
Motor Imagery (MI) paradigm. The paradigm consists of instructing RP, by the use of a mirrored computer screen, to either i) rest his/her mind with eyes open, ii) mentally imagine a hand movement (MI), or ii) execute a hand movement. The hand movements that are instructed are either to close the hand or to open the hand and extend the fingers. RP will perform several repetitions of each hand movement (MI and execution) in order to collect a statistical basis.
Calibration EEG recording. Calibration of EEG recordings will be performed at 2-3 times during 1 week prior to the intervention and one time after the intervention while the participant performs the mental imagery paradigm described above. RP will be seated in front a computer screen and ratings will be registered by the use of a button-press. During these session, EEG, EOG, EMG, and accelerometer-data will be collected and are further described below.
ElectroEncephaloGram (EEG), ElectroOculoGram (EOG), ElectroMyoGram (EMG) and accelerometer equipment. The EEG equipment consists of a 64-electrode scalp EEG acquisition system (Brain Products ActiCHamp). The 64 electrodes (active Ag/AgCl) will be distributed according to the extended 10-20 reference placement system. In addition to the EEG recording, 3 electrodes (passive Ag/AgCl, Brain Products) will be placed on each side of both eyes and on the earlob to measure eye-movements during the experiment (EOG). EMG electrodes (passive Ag/AgCl, Brain Products) will be placed over four muscles controlling the wrist and fingers according to a standardized protocol. Two accelerometer-sensors (Brain Products) will be placed on the hand and the index finger in order to record movement-related activity.
EEG, EOG, EMG and accelerometer data analysis. The recorded data will be further analyzed offline in order to evaluate the characteristic features in the data that best describe MI of hand movements. This will be performed in Matlab and Labview combining custom-made scripts with already developed toolboxes (such as EEGLab, Chronux). Features to be evaluated will include the evoked activity, the time-frequency spectra, phase, correlation coefficients, coherency among other. When the feature that best describes MI has been identified different classifier and pattern recognition methods will be evaluated in extracting the information. Intelligent algorithms, Support Vector Machine (SVM), regularized linear regression, naïve Bayes classifiers among others will be evaluated and compared. These are commonly used methods in the field of neurotechnology and a prior comparison-study using neural data from invasive recordings shows the importance of choosing a well-adapted classifier for extracting information.
MI-NeuroFeedback Training (NFT). EEG, EOG, EMG and accelerometer-data will be collected as described in the section "EEG, EMG and accelerometer equipment". RP will perform the MI paradigm without the execution of hand movements. Real-time feedback from recorded EEG-activity will be provided to RP during MI. The feedback consists of a virtual hand on a computer screen whose movements reflect the brain activity of RP related to MI. The recorded data will be further analyzed offline with the analytic tools that are described in previous section.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Mental imagery neurofeedback training
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental imagery neurofeedback trainingDevice
Mental Imagery (MI)-neurofeedback training, 2-3 hours, 3 times/week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mental imagery neurofeedback training | Experimental | Complete intervention with mental imagery neurofeedback training. Patients recruited by physioterapists who underwent baseline evaluations with clinical tests, fMRI and EEG measurements. Patients will after intervention perform clinical tests, fMRI, and EEG measurements to evaluate outcomes of intervention. Receives: Device: Mental imagery neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Fugl-Meyer Upper Extremity scale score (0-66 points)
Arm and hand function
Measured: Up to 10 weeks
Change of EEG alpha and beta activity
Brain motor network activity reflected in neurofeedback signal
Measured: Up to 7 weeks
Change of fMRI BOLD activity
Brain motor network activity
Measured: Up to 7 weeks
Secondary outcomes (5)
Change of monofilament test score
Two point discrimination and monofilament test for sensory function
Measured: Up to 10 weeks
Change of box and block test score (0-150)
Gross manual dexterity
Measured: Up to 10 weeks
Change of JAMAR® digital Hand Dynamometer scores (0-90)
Grip strength
Measured: Up to 10 weeks
Change of visuomotor force-tracking task scores
Quantification of timing and precision aspects of force grip modulation
Measured: Up to 10 weeks
Change of stroke Impact Scale 16 scores (15-80 points)
Activity limitations related to physical function
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start5 Aug 2019
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, Vinnova
- Responsible party
- Sponsor
- Investigators
- Elaine Astrand, Principal investigator, Mälardalen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994042
- Sponsor's protocol ID
- 2019-01577
- Other IDs
- 2019
- Status last verified
- Jun 2020
- First submitted
- 15 Apr 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.
PubMed 23494615Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27.
PubMed 25712802Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
PubMed 28003656Takemi M, Maeda T, Masakado Y, Siebner HR, Ushiba J. Muscle-selective disinhibition of corticomotor representations using a motor imagery-based brain-computer interface. Neuroimage. 2018 Dec;183:597-605. doi: 10.1016/j.neuroimage.2018.08.070. Epub 2018 Aug 30.
PubMed 30172003Tidare J, Johansson-Alvarez M, Plantin J, Palmcrantz S, Astrand E. Exploration of using 'distance-to-bound' to manipulate the difficulty during motor imagery BCI training after stroke-a clinical two-cases study. J Neural Eng. 2026 Mar 27;23(2). doi: 10.1088/1741-2552/ae512c.
PubMed 41818825
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG-based Mental Imagery Feedback in Stroke Patients With Severe Hand Dysfunction
- ClinicalTrials.gov ID
- NCT03994042
- Acronym / sponsor ID
- 2019-01577
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Vinnova
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 21 Jun 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.
This research project will investigate neurofeedback training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). The investigators hypothesize that the feedback training allows to internally stimulate brain motor networks in order to promote functional recovery of the hand.
Detailed description
This study will be carried out as a pilot study in order to optimize and set parameters for a subsequent study that will involve more stroke patients. Stroke patients will be trained to mentally imagine the opening and closing of the hand (hereafter named MI, Motor Imagery). During the training, the patients will receive visual feedback in real time that reflects the neural activity related to motor processes. The NeuroFeedback (NF) will be projected with minimal time delay to maximize the neural learning. This type of brain training with feedback is thought to have significant importance to stimulate the ability of the brain to reorganize and compensate for a damaged region.
Each participant will go through the following data collection procedure (total of 27-28 measurement sessions per RP):
- Clinical baseline evaluations, 1 time/week during 3 weeks
- 1 MRI measurement during one week
- 2-3 calibration EEG recordings during one week
- MI-neurofeedback training [3 times/week] + Clinical intervention evaluation [1 time/week] during 4 weeks
- 1 MRI measurement + 1 calibration EEG recording during one week
- Clinical intervention evaluations, 1 time/week during 3 weeks
Magnetic Resonance Imaging (MRI) measurements. The MRI exam will be carried out on a Siemens MAGNETOM Prisma 3T scanner (head-coil with 20 channels) at baseline and at final assessment session at Stockholm University Brain Imaging Centre. The MRI protocol comprises i) anatomical whole brain spin-echo T1 and T2 weighted sequences for description of lesion size and location ii) acquisition of T2*-weighted gradient echo EPI-BOLD images of the whole brain for assessment of resting state functional connectivity of sensorimotor networks (resting-state functional MRI (fMRI)), and iii) the same sequence as the previous with rest interleaved by a motor imagery paradigm further described below.
Motor Imagery (MI) paradigm. The paradigm consists of instructing RP, by the use of a mirrored computer screen, to either i) rest his/her mind with eyes open, ii) mentally imagine a hand movement (MI), or ii) execute a hand movement. The hand movements that are instructed are either to close the hand or to open the hand and extend the fingers. RP will perform several repetitions of each hand movement (MI and execution) in order to collect a statistical basis.
Calibration EEG recording. Calibration of EEG recordings will be performed at 2-3 times during 1 week prior to the intervention and one time after the intervention while the participant performs the mental imagery paradigm described above. RP will be seated in front a computer screen and ratings will be registered by the use of a button-press. During these session, EEG, EOG, EMG, and accelerometer-data will be collected and are further described below.
ElectroEncephaloGram (EEG), ElectroOculoGram (EOG), ElectroMyoGram (EMG) and accelerometer equipment. The EEG equipment consists of a 64-electrode scalp EEG acquisition system (Brain Products ActiCHamp). The 64 electrodes (active Ag/AgCl) will be distributed according to the extended 10-20 reference placement system. In addition to the EEG recording, 3 electrodes (passive Ag/AgCl, Brain Products) will be placed on each side of both eyes and on the earlob to measure eye-movements during the experiment (EOG). EMG electrodes (passive Ag/AgCl, Brain Products) will be placed over four muscles controlling the wrist and fingers according to a standardized protocol. Two accelerometer-sensors (Brain Products) will be placed on the hand and the index finger in order to record movement-related activity.
EEG, EOG, EMG and accelerometer data analysis. The recorded data will be further analyzed offline in order to evaluate the characteristic features in the data that best describe MI of hand movements. This will be performed in Matlab and Labview combining custom-made scripts with already developed toolboxes (such as EEGLab, Chronux). Features to be evaluated will include the evoked activity, the time-frequency spectra, phase, correlation coefficients, coherency among other. When the feature that best describes MI has been identified different classifier and pattern recognition methods will be evaluated in extracting the information. Intelligent algorithms, Support Vector Machine (SVM), regularized linear regression, naïve Bayes classifiers among others will be evaluated and compared. These are commonly used methods in the field of neurotechnology and a prior comparison-study using neural data from invasive recordings shows the importance of choosing a well-adapted classifier for extracting information.
MI-NeuroFeedback Training (NFT). EEG, EOG, EMG and accelerometer-data will be collected as described in the section "EEG, EMG and accelerometer equipment". RP will perform the MI paradigm without the execution of hand movements. Real-time feedback from recorded EEG-activity will be provided to RP during MI. The feedback consists of a virtual hand on a computer screen whose movements reflect the brain activity of RP related to MI. The recorded data will be further analyzed offline with the analytic tools that are described in previous section.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mental imagery neurofeedback training | Experimental | Device: Mental imagery neurofeedback trainingComplete intervention with mental imagery neurofeedback training. Patients recruited by physioterapists who underwent baseline evaluations with clinical tests, fMRI and EEG measurements. Patients will after intervention perform clinical tests, fMRI, and EEG measurements to evaluate outcomes of intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- More than 6 months since first time stroke onset and with remaining hemiparesis in upper extremity;
- able to participate fully in the intervention including screening of cognitive function with the Cambridge Neuropsychological Test Automated Battery;
- able to perform Functional Magnetic Resonance Imaging (fMRI);
- able to passively extend the wrist 15 degrees and extend fingers fully with a neutral position of the wrist.
- be able to voluntarily control the power of their grip when requested according to the Visuomotor force tracking method and/or according to the clinical assessment of a therapist (while holding the patient´s hand).
Key exclusion criteria (3 listed)
- Other neurological or musculoskeletal disease/injury, contagious disease or treatment with botulinum toxin in the upper extremity during the past 3 months.
- current or history of epilepsy, hearing problems, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal, infusion device.
- other neurological disorder, pregnancy, current or history of severe psychiatric disorder with need for pharmacological treatment
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 |
|---|---|---|
| Mental imagery neurofeedback trainingMental Imagery (MI)-neurofeedback training, 2-3 hours, 3 times/week for 4 weeks. | Device | Mental imagery neurofeedback training |
Primary outcome
Change of Fugl-Meyer Upper Extremity scale score (0-66 points)
Time frame: Up to 10 weeks
Arm and hand function
Change of EEG alpha and beta activity
Time frame: Up to 7 weeks
Brain motor network activity reflected in neurofeedback signal
Change of fMRI BOLD activity
Time frame: Up to 7 weeks
Brain motor network activity
5 secondary outcomes
Change of monofilament test score
Time frame: Up to 10 weeks
Change of box and block test score (0-150)
Time frame: Up to 10 weeks
Change of JAMAR® digital Hand Dynamometer scores (0-90)
Time frame: Up to 10 weeks
Change of visuomotor force-tracking task scores
Time frame: Up to 10 weeks
Change of stroke Impact Scale 16 scores (15-80 points)
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Background: PubMed 23494615Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.
- Background: PubMed 25712802Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27.
- Background: PubMed 28003656Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
- Background: PubMed 30172003Takemi M, Maeda T, Masakado Y, Siebner HR, Ushiba J. Muscle-selective disinhibition of corticomotor representations using a motor imagery-based brain-computer interface. Neuroimage. 2018 Dec;183:597-605. doi: 10.1016/j.neuroimage.2018.08.070. Epub 2018 Aug 30.
- Derived from this study: PubMed 41818825Tidare J, Johansson-Alvarez M, Plantin J, Palmcrantz S, Astrand E. Exploration of using 'distance-to-bound' to manipulate the difficulty during motor imagery BCI training after stroke-a clinical two-cases study. J Neural Eng. 2026 Mar 27;23(2). doi: 10.1088/1741-2552/ae512c.
- 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.
Elaine Astrand principal investigator
Mälardalen University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental imagery neurofeedback training in people with Stroke and Hemiparesis, run by Mälardalen University at 3 sites in Sweden.
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 9 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Fugl-Meyer Upper Extremity scale score (0-66 points) (time frame: Up to 10 weeks). The study lists 3 primary outcomes in all. 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 NCT03994042, which also lists 5 linked publications.
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 30 Jun 2020.