Linking Digital Smartphone Behaviour With Brain Function

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Brief Title

Linking Digital Smartphone Behaviour With Brain Function

Official Title

Linking Day-to-day Digital Behaviour Captured on the Smartphone With Brain Function in Patients Undergoing Brain Surgery - the "Smart Surgery" Study

Brief 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. 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 Type

Observational


Primary Outcome

Change in pattern of smartphone-assessed day-to-day behaviour

Secondary Outcome

 KPS

Condition

Brain Tumor

Intervention

There is no study-specific intervention

Study Arms / Comparison Groups

 Patients With Brain Tumors/AVMs
Description:  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)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

April 20, 2018

Completion Date

December 2020

Primary Completion Date

April 2020

Eligibility Criteria

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter Brugger, PhD, +41-44-255, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT03516162

Organization ID

BASEC 2018-00395


Responsible Party

Sponsor

Study Sponsor

University of Zurich


Study Sponsor

Peter Brugger, PhD, Study Director, Neuropsychological Unit, Department of Neurology, University Hospital Zurich, Switzerland


Verification Date

May 2019