Intraoperative Functional Ultrasound

NCT ID: NCT02656407

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-11
• Study Completion Date: 2018-02-28

Brief Summary

A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)).

Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent.

This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity.

Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition.

The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI.

Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.

Conditions

Brain Tumor; Brain Lesion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Ultrasensitive Doppler

Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection

Group Type: EXPERIMENTAL

Ultrasound device

Intervention Type: DEVICE

Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device

Interventions

Ultrasound device

Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women, adults ( > 18 years old)
• Participants who have to undergo brain surgery, awake or under general anesthesia, for tumor or lesion resection (all types of tumors and lesions, cortical or subcortical), with programmed intraoperative ultrasound and cortical simulation mapping.
• Consent form signed by the patient after being informed (written and oral) of the research protocol.
• Patient affiliate to the social welfare system

Exclusion Criteria

• Minors ( < 18 years old)
• Pregnant, parturient or breastfeeding women
• Protected persons, under guardianship, or under any administrative or legal right and liberty revocation procedure
• Patient without affiliation to the social welfare system

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorian Chauvet, MD

Role: PRINCIPAL_INVESTIGATOR

Neurosurgery department

Locations

Pitié Salpetriere Hospital

Paris, Île-de-France Region, France

Countries

France

References

Imbault M, Chauvet D, Gennisson JL, Capelle L, Tanter M. Intraoperative Functional Ultrasound Imaging of Human Brain Activity. Sci Rep. 2017 Aug 4;7(1):7304. doi: 10.1038/s41598-017-06474-8.

Reference Type: BACKGROUND

PMID: 28779069 (View on PubMed)

Demene C, Deffieux T, Pernot M, Osmanski BF, Biran V, Gennisson JL, Sieu LA, Bergel A, Franqui S, Correas JM, Cohen I, Baud O, Tanter M. Spatiotemporal Clutter Filtering of Ultrafast Ultrasound Data Highly Increases Doppler and fUltrasound Sensitivity. IEEE Trans Med Imaging. 2015 Nov;34(11):2271-85. doi: 10.1109/TMI.2015.2428634. Epub 2015 Apr 30.

Reference Type: BACKGROUND

PMID: 25955583 (View on PubMed)

Other Identifiers

2015-A00661-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

C14-66

Identifier Type: -

Identifier Source: org_study_id