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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002233
Receipt No. R000002636
Scientific Title Comprehensive study of brain stiffness and brain viscoelasticity measured by tactile biosensor over the scalp
Date of disclosure of the study information 2009/07/22
Last modified on 2014/06/25

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Basic information
Public title Comprehensive study of brain stiffness and brain viscoelasticity measured by tactile biosensor over the scalp
Acronym Brain stiffness over the scalp
Scientific Title Comprehensive study of brain stiffness and brain viscoelasticity measured by tactile biosensor over the scalp
Scientific Title:Acronym Brain stiffness over the scalp
Region
Japan

Condition
Condition inpatient who underwent decompressive craniectomy
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was the quantification of brain stiffness using a tactile biosensor under the condition of increased intracranial pressure at the cranial decompressive site.
Basic objectives2 Others
Basic objectives -Others We studied (1) the correlation between palpation of decompressive window and measurements of a tactile biosensor, (2) the usefulness of variables obtained from hysteresis curve measured by sensor, and (3) the correlation of several items related to degree of brain swelling.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We measured the correlation between degree of palpation and viscoelastic value by tactile biosensor from immediate postoperative day to the day of cranioplasty.
Key secondary outcomes We evaluated neurology and the brain swelling degree of head CT

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria inpatient who underwent decompressive craniectomy due to supratentrial increased intracranial pressure.
Key exclusion criteria posterior fossa decompression, internal decompression of brain cortex, infection, and hemorrhagic tendency
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemasa Nagai
Organization Shimane University Faculty of Medicine
Division name Department of Neurosurgery
Zip code
Address Enya89-1, Izumo city Shimane
TEL 0853-20-2245
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidemasa Nagai
Organization Shimane University Faculty of Medicine
Division name Department of Neurosurgery
Zip code
Address Enya89-1, Izumo city Shimane
TEL 0853-20-2245
Homepage URL
Email h-nagai@shimane-med.ac.jp

Sponsor
Institute Department of Neurosurgery Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 22 Day

Related information
URL releasing protocol http://www.surgicalneurologyint.com
Publication of results Published

Result
URL related to results and publications http://www.surgicalneurologyint.com
Number of participants that the trial has enrolled
Results
Background: Decompressive craniectomy is undertaken for relief of brain herniation caused by acute brain swelling. Brain stiffness can be estimated by palpating the decompressive cranial defect and can provide some relatively subjective information to the neurosurgeon to help guide care. The goal of the present study was to objectively evaluate transcutaneous stiffness of the cranial defect using a tactile resonance sensor and to describe the values in patients with a decompressive window in order to characterize the clinical association between brain edema and stiffness.
Methods: Data were prospectively collected from 13 of 37 patients who underwent a decompressive craniectomy in our hospital during a 5-year period. Transcutaneous stiffness was measured as change in frequency and as elastic modulus.
Results: Stiffness variables of the decompressive site were measured without
any adverse effect and subsequent calculations revealed change in frequency =101.71/36.42 Hz, and shear elastic modulus =1.99/1.11 kPa.
Conclusions: The elasticity of stiffness of a decompressive site correlated with
brain edema, cisternal cerebrospinal fluid pressure, and brain shift, all of which are related to acute brain edema.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 Month 22 Day
Date of closure to data entry
2014 Year 06 Month 23 Day
Date trial data considered complete
2014 Year 06 Month 24 Day
Date analysis concluded
2014 Year 06 Month 25 Day

Other
Other related information Elastic modulus measured by spherical indentation used toward the clinical
application of the brain stiffness]. Brain Nerve. 2013,65(1):85-92. Japanese.

OBJECTIVE: Palpation of brain stiffness is one of techniques that leads to successful neurosurgical procedures. In order to evaluate brain stiffness quantitatively, we studied the potential clinical applicability of a spherical indenting tactile sensor.
METHODS: The sensor had a spherical rigid indenter (diameter=5.0 mm; contact pressure=1.0 gf/mm2), and the indenter was rapidly pushed and pulled at a constant speed by a computer-controlled motor. The pressure-depth hysteresis curve was obtained using the sensor, and the shear elastic modulus (G) was calculated on the basis of the Hertz contact theory. We adopted the G-value at the maximum depth (G_max) as an indicator of brain stiffness.
RESULTS: First, to calibrate the sensor, we investigated the elasticity of silicone plates. The optimal settings for clinical application was an indenting speed of 1.5 mm/s and an indenting maximum depth of 2-3 mm. Next, we measured the elasticity of a decompressive site in 7 patients who had been stable for more than 21 days after undergoing decompressive craniectomy. The G_max of the decompressive site was 1.71/0.75 kPa. Finally, we measured the intraoperative brain elasticity in a case of brain tumor with severe brain edema. The transdural elasticity of the edematous brain was G=4.87 kPa, and the direct elasticity of the brain surface decreased to G=4.34 kPa after dura incision.
CONCLUSIONS: The spherical indentation method for measuring brain elasticity seems applicable to neurosurgical procedures.

Management information
Registered date
2009 Year 07 Month 22 Day
Last modified on
2014 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002636

Research Plan
Registered date File name

Research case data specifications
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Research case data
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