SmartSurgery
Linking Day-to-day Digital Behaviour Captured on the Smartphone With Brain Function in Patients Undergoing Brain Surgery - the "Smart Surgery" Study
Sponsor study identifier
observational
100
1 country
1
Study Start
April 20, 2018
Actual (reported)Primary Completion
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 20, 2018
Actual (reported)April 20, 2018
Actual (reported)May 4, 2018
Actual (reported)April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
One week before surgery until the follow-up three months after surgery
KPS
One week before surgery until the follow-up three months after surgery
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)
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)
There is no study-specific intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
University Hospital Zurich
Zurich, 8091, Switzerland
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.
Peter Brugger, PhD
Neuropsychological Unit, Department of Neurology, University Hospital Zurich, Switzerland
Arko Ghosh, PhD
Faculty of Social and Behavioural Sciences, Leiden University, Netherlands
Luca Regli, MD
Department of Neurosurgery, University Hospital Zurich
First Submitted
April 20, 2018
First Posted
May 4, 2018
Study Start
April 20, 2018
Actual (reported)Primary Completion
April 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Bridging Brain Structure and Function by Correlating Structural Connectivity, Cortico-Cortical Transmission and Direct Electro-Stimulation
Monitoring MRI Changes Before and During Radiotherapy Treatment of Brain Tumors
NIHSS
One week before surgery until the follow-up three months after surgery
MoCA score
One week before surgery until the follow-up three months after surgery
Domain-specific z-scores of neuropsychological functioning, age-, sex- and education-adjusted
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
One week before surgery until the follow-up three months after surgery
General remarks
One week before surgery until the follow-up three months after surgery
Contact the study team to confirm eligibility.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 24, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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