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Multimodal Connectome Study of Brain Tumor-operated Patients

Study Purpose

In this pilot study, the investigators propose a multimodal evaluation of the brain connectivity of brain tumor patients, in order to better understand the effects induced by focal lesions on brain structure and function, as well as brain plasticity mechanisms that may occur in such condition. The investigators aim at drawing a multimodal brain connectivity map of focally brain-damaged patients, with a view to improve onco-functional neurosurgical practices.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - All patients with brain tumor for removal.
  • - Age > 18 years.
  • - Informed patient consent.
  • - Membership of social security scheme.

Exclusion Criteria:

  • - Contraindication to MRI.
  • - Any subject with vascular stent implanted less than 6 weeks prior to the exam; - Any subject carrying an intraocular or intracranial ferromagnetic foreign object close to nerve structures; - Any subject carrying biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained in the performance of MRI in these subjects; - Presence of more than one brain tumor.
  • - Refusal of patient participation.
  • - Pregnant or nursing women.
A urinary pregnancy test will be conducted for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
  • - Person staying in a health or social establishment.
  • - Person in emergency situation.
- Vulnerable patient: deprived of liberty, guardianship, curators, or safeguarding of justice

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04163315
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Centre Hospitalier Universitaire de Nice
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Fabien ALMAIRAC, MD, PhD
Principal Investigator Affiliation Centre Hospitalier Universitaire de Nice
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Tumor, Brain
Additional Details

Patients included in the present study will first perform the pre-operative MRI (dMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional acquisition at rest. Then, the investigators will record their cortico-cortical evoked potentials elicited by direct electrostimulation during the surgery, just before the tumor removal, following our usual protocol. Finally, all data (clinical, diffusion, electrical and functional connectivity) will be processed and correlated to each other.

Arms & Interventions

Arms

Experimental: dMRI, fMRI and electrocorticography

With this exploratory pilot study, the investigator propose a multimodal evaluation of the structural and functional connectivity of patients with brain tumours, in order to better understand the tumor-induced lesion mechanisms on brain connectivity as well as the brain plasticity mechanisms that the brain develops to maintain a level of overall function neurological. The investigator hope to obtain multimodal brain mapping of locally brain-damaged patients, with a view to improving onco-functional neurosurgical practices.

Interventions

Other: - dMRI, fMRI and electrocorticography

Patients included in the study will perform the pre-operative MRI (fMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional rest sequence. The additional scan time for this specific sequence is approximately 25 minutes, with no foreseeable negative impact on the patient

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Nice, Nice, Chu de Nice, France

Status

Recruiting

Address

CHU de Nice

Nice, Chu de Nice, 06003

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