Brain TumorSmartSurgeryNCT03516162
Linking Digital Smartphone Behaviour With Brain Function
An observational study of Brain Tumor and Hydrocephalus, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study will thus examine daily behaviour based on smartphone use and link it to the neurological and neuropsychological status as well as to neuroradiological studies that are part of the clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Hydrocephalus, Arteriovenous Malformations
- What is being tested?
- There is no study-specific intervention
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Apr 2018to Dec 2020
- Phase
- Observational
- 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
Study population: The project will include n=50 patients with a brain tumour/AVM scheduled for maximum safe resection via craniotomy and n=50 patients with hydrocephalus scheduled for VP-shunting.
Who may be able to join
- Consent of the patient
- Age: ≥18
- Fluent language skills in German
- Patient is scheduled for either maximum safe resection of a brain tumour/AVM via craniotomy or VP-shunting for hydrocephalus
- Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months
- Preoperative smartphone-assessed day-to-day behaviour can be recorded for at least 1 week (7 days)
Who cannot join
- Presence of known neurologic or psychiatric disease other than brain tumour/AVM or hydrocephalus that can potentially influence the performance of a patient while using the smartphone (e.g. dementia, multiple sclerosis, bipolar disorder)
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
- Patients enrolled in a different clinical trial according to KlinV (participation in another research project according to HFV is allowed, if this is not a burden to the patient)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Martin N Stienen, MD, FEBNS, +4144255 ext. 1111, mnstienen@gmail.com
Kevin Akeret, MD
About this study
Official title: Linking Day-to-day Digital Behaviour Captured on the Smartphone With Brain Function in Patients Undergoing Brain Surgery - the "Smart Surgery" Study
This study will thus examine daily behaviour based on smartphone use and link it to the neurological and neuropsychological status as well as to neuroradiological studies that are part of the clinical routine. The study will examine behaviour changes before and after surgery, and how this change in measured behaviour with the smartphone relates to today's "gold standard", namely professional neuropsychological examination and quantification of brain damage on imaging studies (MRI).
This study is a proof-of-principle study that intends to build the basis for larger future observational studies on patients with focal or diffuse brain pathologies.
Read the detailed description
Pathologies of the central nervous system (CNS), as well as their surgical treatment, may interfere with the physiological and behavioural functions of the human brain. Commonly, before and after surgical treatment, the neurosurgeon examines the patient carefully for neurological deficits and additionally asks neuropsychologists to evaluate higher cognitive functions. These examinations, however, only represent the situation at a given point in time, and currently longitudinal or continuous evaluation of physiological and behavioural functions of the human brain is highly limited. Furthermore, in the conventional examinations the complex human behaviour is reduced to very simplified scores (e.g. the NIHSS for neurological or MoCA for neuropsychological functioning). Fluctuations in physiological and behavioural functions are very likely, but are unlikely to be captured with current evaluations at single (discrete) pre- and postoperative points in time. To date, "on-line" continuous evaluation of brain function in patients undergoing (potentially risky) neurosurgical procedures has not been established.
The touchscreen interface of smartphones offers a fresh avenue to capture day-to-day behaviour (engagement of finger tips) by exploiting the technology intrinsic to a smartphone. For instance, the speed of touchscreen use, the distinct behavioural contexts (compartmentalised into Apps) and the corresponding habits can be seamlessly and non-obtrusively captured. More importantly, compared with current discrete approaches of evaluation, this continuous approach can account for - and even exploit - the natural fluctuations in brain functions.
Nevertheless, behavioural data from touchscreens is new to scientific exploration and various fundamental questions remain to be answered, such as what are the basic statistical features of smartphone behaviour, how does this behaviour vary from one day to another, and how does this behaviour reflect basic demographic information? This gap in our understanding of smartphone behavioural data also implies that the exact statistical methods to be employed may need to undergo adjustments. For instance, the common central tendency measure of the sample mean may be highly unstable if the parameter/s occupy a power-law distribution rather than a Poisson or Gaussian distribution. In summary, ever-new exploration of the neuroscience of touchscreen behaviour must trigger the right choice of analytical and statistical methods.
The focus of this study is laid on patients with pathologies of the CNS. The investigators aim to examine both patients with diffuse and focal pathologies. In order to study diffuse pathologies, the investigators will include patients with hydrocephalus. In order to study focal pathologies, the investigators will include patients with brain tumours or arteriovenous malformations (AVMs) - which are localised and described using clinical neuroimaging. Patients will be examined before and after a neurosurgical procedure.
At the "UniversitätsSpital Zürich", both patients with hydrocephalus that are scheduled for ventriculo-peritoneal (VP)-shunting and patients with brain tumours/AVMs that are scheduled for microsurgical resection routinely undergo a neurosurgical, neuropsychological and neuroradiological examination (by MRI) preoperatively and at 3 months postoperative (for clinical purpose). Patients that agree to participate in this study will install a free App (programmed by the University of Zurich (UZH) spin-off QuantActions and freely available on the Google Play store) on their smartphone that records their day-to-day physiological and behavioural status associated with use of the hand (smartphone touchscreen). The study will examine behaviour changes before and after surgery, and how this change in measured behaviour with the smartphone relates to the neuropsychological examination and quantification of brain damage on imaging studies (MRI).
- Conditions
- Brain Tumor, Hydrocephalus, Arteriovenous Malformations
- Being tested
- There is no study-specific intervention
- Keywords
- Behaviour, Brain Tumor, Hydrocephalus, Smartphone, Big Data, Neuropsychology, Neuroradiology, Neurosurgery, Outcome Assessment, Functional Impairment, Cognitive Function, Touchscreen, Arteriovenous malformation, AVM
- Medical subject headings
- Brain Neoplasms, Hydrocephalus, Arteriovenous Malformations, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no study-specific interventionOther
There is no study-specific intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients With Brain Tumors/AVMs | Patients with a brain tumour/AVM scheduled for maximum safe resection via craniotomy.
Participants fulfilling all of the following inclusion criteria are eligible for the study:
* Consent of the patient
* Age: ≥18
* Fluent language skills in German
* Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months
* Preoperative smartphone-assessed day-to-day behaviour can be recorded for at least 1 week (7 days) Receives: Other: There is no study-specific intervention | |
| Patients With Hydrocephalus | Patients with hydrocephalus scheduled for VP-shunting Participants fulfilling all of the following inclusion criteria are eligible for the study: * Consent of the patient * Age: ≥18 * Fluent language skills in German * Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months * Preoperative smartphone-assessed day-to-day behaviour can be recorded for at least 1 week (7 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pattern of smartphone-assessed day-to-day behaviour
For the primary endpoint, the patterns of smartphone-assessed day-to-day behaviour in the time period before the operation (day -7 until day 0) will be graphically illustrated and compared for obvious differences to the behaviour in the first postoperative week (+7 days) and in the week before the postoperative consultation at three months after the operation. Towards this we shall employ exhaustive statistical and numerical methods that are typical of complex systems research. This includes comparing the patterns in defined parameter space, clustering of patterns dependent on the diseased state and defining new parameter spaces where the data conforms to the working hypothesis.
Measured: One week before surgery until the follow-up three months after surgery
Secondary outcomes (8)
KPS
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
NIHSS
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
MoCA score
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
Domain-specific z-scores of neuropsychological functioning, age-, sex- and education-adjusted
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
For patients with a brain tumour, location of the lesion, as determined on MRI imaging
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
For patients with a brain tumour, the size of the lesion
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
For patients with a brain tumour, the degree of affected brain tissue as seen on early (within 5 days) or late postoperative MRI (3 months)
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
For patients with hydrocephalus, ventricular enlargement, as determined on MRI imaging, according to the Evans index (=A/E); Third ventricle index (= C/E); Cella media index (=D/F); Ventricular score (=(A+B+C+D)/E x 100)
For the secondary endpoints, several scores have to be correlated to the complex data generated. Towards this we shall deploy large-scale multivariate approaches that span various time scales - from ms to hours, and that are conducted using sweeping windows across the entire period recording. By using statistical clustering methods, we shall correct for multiple comparison when inferring our data.
Measured: One week before surgery until the follow-up three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start20 Apr 2018
- Primary completionApr 2020 (estimated)
- Study completionDec 2020 (estimated)
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 Brain TumorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Brugger, PhD, Study director, Neuropsychological Unit, Department of Neurology, University Hospital Zurich, SwitzerlandArko Ghosh, PhD, Study director, Faculty of Social and Behavioural Sciences, Leiden University, NetherlandsLuca Regli, MD, Study chair, Department of Neurosurgery, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516162
- Sponsor's protocol ID
- BASEC 2018-00395
- Acronym
- SmartSurgery
- Status last verified
- May 2019
- First submitted
- 20 Apr 2018
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akeret K, Vasella F, Geisseler O, Dannecker N, Ghosh A, Brugger P, Regli L, Stienen MN. Time to be "smart"-Opportunities Arising From Smartphone-Based Behavioral Analysis in Daily Patient Care. Front Behav Neurosci. 2018 Dec 4;12:303. doi: 10.3389/fnbeh.2018.00303. eCollection 2018.
PubMed 30568582
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Day-to-day Digital Behaviour Captured on the Smartphone With Brain Function in Patients Undergoing Brain Surgery - the "Smart Surgery" Study
- ClinicalTrials.gov ID
- NCT03516162
- Acronym / sponsor ID
- SmartSurgery / BASEC 2018-00395
- Conditions
- Brain Tumor, Hydrocephalus, Arteriovenous Malformations
- Keywords
- Behaviour, Brain Tumor, Hydrocephalus, Smartphone, Big Data, Neuropsychology, Neuroradiology, Neurosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 May 2018 (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 study will thus examine daily behaviour based on smartphone use and link it to the neurological and neuropsychological status as well as to neuroradiological studies that are part of the clinical routine. The study will examine behaviour changes before and after surgery, and how this change in measured behaviour with the smartphone relates to today's "gold standard", namely professional neuropsychological examination and quantification of brain damage on imaging studies (MRI).
This study is a proof-of-principle study that intends to build the basis for larger future observational studies on patients with focal or diffuse brain pathologies.
Detailed description
Pathologies of the central nervous system (CNS), as well as their surgical treatment, may interfere with the physiological and behavioural functions of the human brain. Commonly, before and after surgical treatment, the neurosurgeon examines the patient carefully for neurological deficits and additionally asks neuropsychologists to evaluate higher cognitive functions. These examinations, however, only represent the situation at a given point in time, and currently longitudinal or continuous evaluation of physiological and behavioural functions of the human brain is highly limited. Furthermore, in the conventional examinations the complex human behaviour is reduced to very simplified scores (e.g. the NIHSS for neurological or MoCA for neuropsychological functioning). Fluctuations in physiological and behavioural functions are very likely, but are unlikely to be captured with current evaluations at single (discrete) pre- and postoperative points in time. To date, "on-line" continuous evaluation of brain function in patients undergoing (potentially risky) neurosurgical procedures has not been established.
The touchscreen interface of smartphones offers a fresh avenue to capture day-to-day behaviour (engagement of finger tips) by exploiting the technology intrinsic to a smartphone. For instance, the speed of touchscreen use, the distinct behavioural contexts (compartmentalised into Apps) and the corresponding habits can be seamlessly and non-obtrusively captured. More importantly, compared with current discrete approaches of evaluation, this continuous approach can account for - and even exploit - the natural fluctuations in brain functions.
Nevertheless, behavioural data from touchscreens is new to scientific exploration and various fundamental questions remain to be answered, such as what are the basic statistical features of smartphone behaviour, how does this behaviour vary from one day to another, and how does this behaviour reflect basic demographic information? This gap in our understanding of smartphone behavioural data also implies that the exact statistical methods to be employed may need to undergo adjustments. For instance, the common central tendency measure of the sample mean may be highly unstable if the parameter/s occupy a power-law distribution rather than a Poisson or Gaussian distribution. In summary, ever-new exploration of the neuroscience of touchscreen behaviour must trigger the right choice of analytical and statistical methods.
The focus of this study is laid on patients with pathologies of the CNS. The investigators aim to examine both patients with diffuse and focal pathologies. In order to study diffuse pathologies, the investigators will include patients with hydrocephalus. In order to study focal pathologies, the investigators will include patients with brain tumours or arteriovenous malformations (AVMs) - which are localised and described using clinical neuroimaging. Patients will be examined before and after a neurosurgical procedure.
At the "UniversitätsSpital Zürich", both patients with hydrocephalus that are scheduled for ventriculo-peritoneal (VP)-shunting and patients with brain tumours/AVMs that are scheduled for microsurgical resection routinely undergo a neurosurgical, neuropsychological and neuroradiological examination (by MRI) preoperatively and at 3 months postoperative (for clinical purpose). Patients that agree to participate in this study will install a free App (programmed by the University of Zurich (UZH) spin-off QuantActions and freely available on the Google Play store) on their smartphone that records their day-to-day physiological and behavioural status associated with use of the hand (smartphone touchscreen). The study will examine behaviour changes before and after surgery, and how this change in measured behaviour with the smartphone relates to the neuropsychological examination and quantification of brain damage on imaging studies (MRI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Brain Tumors/AVMs | – | Other: There is no study-specific interventionPatients with a brain tumour/AVM scheduled for maximum safe resection via craniotomy. Participants fulfilling all of the following inclusion criteria are eligible for the study: * Consent of the patient * Age: ≥18 * Fluent language skills in German * Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months * Preoperative smartphone-assessed day-to-day behaviour can be recorded for at least 1 week (7 days) |
| Patients With Hydrocephalus | – | –Patients with hydrocephalus scheduled for VP-shunting Participants fulfilling all of the following inclusion criteria are eligible for the study: * Consent of the patient * Age: ≥18 * Fluent language skills in German * Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months * Preoperative smartphone-assessed day-to-day behaviour can be recorded for at least 1 week (7 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The project will include n=50 patients with a brain tumour/AVM scheduled for maximum safe resection via craniotomy and n=50 patients with hydrocephalus scheduled for VP-shunting.
Key inclusion criteria (6 listed)
- Consent of the patient
- Age: ≥18
- Fluent language skills in German
- Patient is scheduled for either maximum safe resection of a brain tumour/AVM via craniotomy or VP-shunting for hydrocephalus
- Patient is capable to use a smartphone (based on the Google Android system) and uses a smartphone since at least 3 months
Key exclusion criteria (3 listed)
- Presence of known neurologic or psychiatric disease other than brain tumour/AVM or hydrocephalus that can potentially influence the performance of a patient while using the smartphone (e.g. dementia, multiple sclerosis, bipolar disorder)
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
- Patients enrolled in a different clinical trial according to KlinV (participation in another research project according to HFV is allowed, if this is not a burden to the patient)
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 |
|---|---|---|
| There is no study-specific interventionThere is no study-specific intervention | Other | Patients With Brain Tumors/AVMs |
Primary outcome
Change in pattern of smartphone-assessed day-to-day behaviour
Time frame: One week before surgery until the follow-up three months after surgery
For the primary endpoint, the patterns of smartphone-assessed day-to-day behaviour in the time period before the operation (day -7 until day 0) will be graphically illustrated and compared for obvious differences to the behaviour in the first postoperative week (+7 days) and in the week before the postoperative consultation at three months after the operation. Towards this we shall employ exhaustive statistical and numerical methods that are typical of complex systems research. This includes comparing the patterns in defined parameter space, clustering of patterns dependent on the diseased state and defining new parameter spaces where the data conforms to the working hypothesis.
8 secondary outcomes
KPS
Time frame: One week before surgery until the follow-up three months after surgery
NIHSS
Time frame: One week before surgery until the follow-up three months after surgery
MoCA score
Time frame: One week before surgery until the follow-up three months after surgery
Domain-specific z-scores of neuropsychological functioning, age-, sex- and education-adjusted
Time frame: One week before surgery until the follow-up three months after surgery
For patients with a brain tumour, location of the lesion, as determined on MRI imaging
Time frame: One week before surgery until the follow-up three months after surgery
For patients with a brain tumour, the size of the lesion
Time frame: One week before surgery until the follow-up three months after surgery
For patients with a brain tumour, the degree of affected brain tissue as seen on early (within 5 days) or late postoperative MRI (3 months)
Time frame: One week before surgery until the follow-up three months after surgery
For patients with hydrocephalus, ventricular enlargement, as determined on MRI imaging, according to the Evans index (=A/E); Third ventricle index (= C/E); Cella media index (=D/F); Ventricular score (=(A+B+C+D)/E x 100)
Time frame: One week before surgery until the follow-up three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Derived from this study: PubMed 30568582Akeret K, Vasella F, Geisseler O, Dannecker N, Ghosh A, Brugger P, Regli L, Stienen MN. Time to be "smart"-Opportunities Arising From Smartphone-Based Behavioral Analysis in Daily Patient Care. Front Behav Neurosci. 2018 Dec 4;12:303. doi: 10.3389/fnbeh.2018.00303. eCollection 2018.
- Link to the "TapCounter" appLink provided by the sponsor.
- Link to QuantActions GmbH, Lausanne, SwitzerlandLink provided by the sponsor.
- 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.
Peter Brugger, PhD study director
Neuropsychological Unit, Department of Neurology, University Hospital Zurich, Switzerland
Arko Ghosh, PhD study director
Faculty of Social and Behavioural Sciences, Leiden University, Netherlands
Luca Regli, MD study chair
Department of Neurosurgery, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Hydrocephalus, run by University of Zurich at 1 site in Switzerland.
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 6 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: status not confirmed, as of the sponsor's last update on 24 May 2019. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin N Stienen, MD, FEBNS (+41-44-255 ext. 1111, mnstienen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pattern of smartphone-assessed day-to-day behaviour (time frame: One week before surgery until the follow-up three months after surgery). 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 NCT03516162, 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 24 May 2019.