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

Centre Jean Perrin

Status: Completed

Conditions: Glioma

Treatments: Device: noninvasive method of ICP measurements (Elios)

Study type: Interventional

Funder types: Other

Identifiers

NCT02520492

2014-A01568-39

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

noninvasive method of ICP measurements

Experimental group

Description:

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.

Treatment:

Device: noninvasive method of ICP measurements (Elios)