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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Martin N Stienen, MD, FEBNS contact

+41-44-255 ext. 1111

mnstienen@gmail.com

Switzerland1 site, 1 recruiting
  • University Hospital Zurich

    Zurich, 8091

    Martin N Stienen, MD, FEBNS, +4144255 ext. 1111, mnstienen@gmail.com

    Kevin Akeret, MD

    Recruiting

Other trials in Switzerland

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).

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 groups in NCT03516162
Study groupRoleWhat they receive
Patients With Brain Tumors/AVMsPatients 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 HydrocephalusPatients 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted4 May 2018
  2. Study start20 Apr 2018
  3. Primary completionApr 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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)
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

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.

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