Linking Digital Smartphone Behaviour With Brain Function
NCT ID: NCT03516162
Last Updated: 2019-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2018-04-20
2020-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
There is no study-specific intervention
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)
No interventions assigned to this group
Interventions
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There is no study-specific intervention
There is no study-specific intervention
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Peter Brugger, PhD
Role: STUDY_DIRECTOR
Neuropsychological Unit, Department of Neurology, University Hospital Zurich, Switzerland
Arko Ghosh, PhD
Role: STUDY_DIRECTOR
Faculty of Social and Behavioural Sciences, Leiden University, Netherlands
Luca Regli, MD
Role: STUDY_CHAIR
Department of Neurosurgery, University Hospital Zurich
Locations
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University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Link to the "TapCounter" app
Link to QuantActions GmbH, Lausanne, Switzerland
Other Identifiers
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BASEC 2018-00395
Identifier Type: -
Identifier Source: org_study_id
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