Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma (GMaPIC)

January 30, 2020 updated by: Centre Jean Perrin

In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.

A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.

A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination of causes: the inflammatory reaction around the tumor, the mass effect of the tumor, secondary vascular changes, a change in the flow of CSF.

The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the monitoring of intracranial tumors. It is then detected by using routine clinical signs, in combination with a standard imaging method (MRI), but still subjective.

The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate whether the increase in ICP precedes tumor clinical worsening and / or imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with malignant glioma who underwent a biopsy or a partial surgery of this tumor and a radiotherapy and/or chemotherapy treatment.
  • Valid tympanometry test at least for one ear
  • Between 18 and 65 years of age
  • Cochlear response useful at least for an ear which has validate the tympanometry test
  • Written informed consent reviewed and signed by patient
  • Affiliation to a social security scheme

Exclusion Criteria:

  • Patients who underwent a complete resection of their malignant glioma
  • Invalid tympanometry test for the both ears
  • Collect of cochlear responses impossible for the ear or both ear which validate the tympanometry test
  • Patient refusal after enlightened information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: noninvasive method of ICP measurements

Patients will receive a noninvasive measurement of ICP variations during each of their follow up consultation. These measurements will last until 30 minutes for the first consultation (parameters to determine) and 10 minutes for the others. A postural test will be performed during the ICP measurements when the patient condition will make it possible to do.

Measurements will be performed by a device with noninvasive acoustic probes placed in the ear, and in case of electrophysiological test, regular electrodes on the brow.
Device: noninvasive method of ICP measurements (Elios)
Other Names:
  • Elios device from ECHODIA company

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of an ICP variation or increase when physician has diagnosed a clinical or morphological aggravation of the tumor with standard diagnose methods (composite outcome measure)
Time Frame: from baseline to 1 year
Presence of an ICP variation or increase when physician has diagnosed a clinical or morphological aggravation of the tumor with standard diagnose methods (composite outcome measure ) : clinical signs, MRI and response assessment in neuro-oncology criteria (RANO) .
from baseline to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)
Time Frame: from baseline to 1 year
from baseline to 1 year
evolution of ICP before and after the progression of the relapse tumor according to clinical sign
Time Frame: from baseline to 1 year
from baseline to 1 year
Evaluate efficiency of the measurement device of ICP changes on repetitive measurement as evaluated by composite outcome measure : clinical signs, MRI and RANO criteria
Time Frame: from baseline to 1 year
from baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Collaborators

Laboratoire de Biophysique Neurosensorielle - UMR INSERM 1107 (Pr Paul AVAN)

Investigators

  • Principal Investigator: Xavier DURANDO, MD, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2015

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01568-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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