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Linking Digital Smartphone Behaviour With Brain Function (SmartSurgery)

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ClinicalTrials.gov Identifier: NCT03516162
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.


Condition or disease Intervention/treatment
Brain Tumor Hydrocephalus Other: There is no study-specific intervention

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 - 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 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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Linking Day-to-day Digital Behaviour Captured on the Smartphone With Brain Function in Patients Undergoing Brain Surgery - the "Smart Surgery" Study
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients With Brain Tumors

Patients with a brain tumour 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)
Other: 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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. KPS [ Time Frame: One week before surgery until the follow-up three months after surgery ]
    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.

  2. NIHSS [ Time Frame: One week before surgery until the follow-up three months after surgery ]
    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.

  3. MoCA score [ Time Frame: One week before surgery until the follow-up three months after surgery ]
    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.

  4. 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 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.

  5. 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 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.

  6. 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 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.

  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) [ Time Frame: One week before surgery until the follow-up three months after surgery ]
    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.

  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) [ Time Frame: One week before surgery until the follow-up three months after surgery ]
    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.


Other Outcome Measures:
  1. General remarks [ Time Frame: One week before surgery until the follow-up three months after surgery ]

    For each individual patient, the secondary endpoints before and after surgery will be compared (in-subject differences) and related to the patterns of smartphone-assessed day-to-day behaviour.

    In general, patients with brain tumours and patients with hydrocephalus are analysed separately.

    As this study is a proof-of-concept study, no formal sample size calculation is performed.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The project will include n=50 patients with a brain tumour scheduled for maximum safe resection via craniotomy and n=50 patients with hydrocephalus scheduled for VP-shunting.
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 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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516162


Contacts
Contact: Martin N Stienen, MD, FEBNS +41-44-255 ext 1111 mnstienen@gmail.com
Contact: Luca Regli, MD +41-44-255 ext 1111 luca.regli@usz.ch

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Martin N Stienen, MD, FEBNS    +4144255 ext 1111    mnstienen@gmail.com   
Sub-Investigator: Kevin Akeret, MD         
Sub-Investigator: Flavio Vasella, MD         
Sub-Investigator: Olivia Geisseler, PhD         
Sub-Investigator: Noemi Dannecker, MSc         
Sub-Investigator: Peter Brugger, PhD         
Sub-Investigator: Oliver Bozinov, MD         
Sub-Investigator: Niklaus Krayenbühl, MD         
Sub-Investigator: Lennart Stieglitz, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: Peter Brugger, PhD Neuropsychological Unit, Department of Neurology, University Hospital Zurich, Switzerland
Study Director: Arko Ghosh, PhD Faculty of Social and Behavioural Sciences, Leiden University, Netherlands
Study Chair: Luca Regli, MD Department of Neurosurgery, University Hospital Zurich

Additional Information:
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03516162     History of Changes
Other Study ID Numbers: BASEC 2018-00395
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
Brain Tumor
Behaviour
Hydrocephalus
Smartphone
Big Data
Neuropsychology
Neuroradiology
Neurosurgery
Outcome Assessment
Functional Impairment
Cognitive Function
Touchscreen

Additional relevant MeSH terms:
Brain Neoplasms
Hydrocephalus
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases