Skip to main content
OpenTrials
Completed

NCT Number: NCT02520492

Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

noninvasive method of ICP measurements (Elios)

Device

Other names: Elios device from ECHODIA company

Primary outcomes

  1. 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) .

Secondary outcomes

  1. evolution of ICP before and after the progression of the relapse tumor according to imaging (RMI)

    Time frame: from baseline to 1 year

  2. evolution of ICP before and after the progression of the relapse tumor according to clinical sign

    Time frame: from baseline to 1 year

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Collaborators

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

Registry information

Acronym: GMaPIC

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2015
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.