Inside a Neuron - Ex Vivo Evaluation of Cerebral and Cerebellar Neuronal Activity. (INSANE)

March 19, 2025 updated by: Francesco Guerrini, Fondazione IRCCS Policlinico San Matteo di Pavia

Inside a Neuron - Ex Vivo Evaluation of Cerebral and Cerebellar Neuronal Activity Through Electrophysiological and Imaging Techniques on Human Tissue from Surgical Activity.

Understanding the functioning of human neurons has always been a key element, especially with regard to the translation of the inputs they receive into actions that determine human behavior. However, the vast majority of studies have been performed in animal models due to the difficulty in maintaining neuronal functions ex vivo. Recently, techniques have been illustrated that allow us to obtain slices of brain tissue removed during neurosurgical interventions. The patch-clamp and HD-MEA (high density - microelectrodes array) techniques, used until now for animal samples, can allow us to study the functioning of the neural cells that make up these slices. Furthermore, the exploration of the functioning of the aforementioned cells in pathological conditions can open the field for further therapeutic perspectives.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo di Pavia
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with a brain/cerebellum primary or secondary tumor.

Description

Inclusion Criteria:

  • patients with a brain/cerebellum primary or secondary tumor for whom at least partial resection has been planned.

Exclusion Criteria:

  • patients with a brain/cerebellum primary or secondary tumor for whom a biopsy has been planned

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

Cohorts and Interventions

Group / Cohort
Study group
Patients subdued to neurosurgical intervention for the removal of brain or cerebellum primary or secondary tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: Through study completion, an average of 3 years.

Intrinsic and extrinsic properties of brain and cerebellum neurons in "health" condition. In particular, following element will be measured:

  • cell membrane capacity and resistance;
  • Sodium and Potassium currents;
  • cell firing frequency.
Through study completion, an average of 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary endpoint
Time Frame: Through study completion, an average of 3 years.

Intrinsic and extrinsic properties of brain and cerebellum neurons in "pathological" condition.

In particular, following element will be measured:

  • cell membrane capacity and resistance;
  • Sodium and Potassium currents; - cell firing frequency.
Through study completion, an average of 3 years.

Collaborators and Investigators

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

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

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)

September 17, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Estimated)

March 26, 2025

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INSANE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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