Human Neural Cells FunctioningINSANENCT06896331
Inside a Neuron - Ex Vivo Evaluation of Cerebral and Cerebellar Neuronal Activity.
An observational study of Human Neural Cells Functioning, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Neural Cells Functioning
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a brain/cerebellum primary or secondary tumor.
Who may be able to join
- patients with a brain/cerebellum primary or secondary tumor for whom at least partial resection has been planned.
Who cannot join
- patients with a brain/cerebellum primary or secondary tumor for whom a biopsy has been planned
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
Francesco Guerrini, MD, +39 0382502780, f.guerrini@smatteo.pv.it
About this study
Official title: 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.
- Conditions
- Human Neural Cells Functioning
- Keywords
- INSANE, neurons, human, glioma, brain, patch-clamp, HD-MEA
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients subdued to neurosurgical intervention for the removal of brain or cerebellum primary or secondary tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
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.
Measured: Through study completion, an average of 3 years.
Secondary outcomes (1)
Secondary endpoint
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.
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start17 Sep 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Neural Cells FunctioningStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Guerrini, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896331
- Sponsor's protocol ID
- INSANE
- Acronym
- INSANE
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inside a Neuron - Ex Vivo Evaluation of Cerebral and Cerebellar Neuronal Activity Through Electrophysiological and Imaging Techniques on Human Tissue from Surgical Activity.
- ClinicalTrials.gov ID
- NCT06896331
- Acronym / sponsor ID
- INSANE / INSANE
- Conditions
- Human Neural Cells Functioning
- Keywords
- INSANE, neurons, human, glioma, brain, patch-clamp, HD-MEA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients subdued to neurosurgical intervention for the removal of brain or cerebellum primary or secondary tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a brain/cerebellum primary or secondary tumor.
Key inclusion criteria (1 listed)
- patients with a brain/cerebellum primary or secondary tumor for whom at least partial resection has been planned.
Key exclusion criteria (1 listed)
- patients with a brain/cerebellum primary or secondary tumor for whom a biopsy has been planned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Secondary endpoint
Time frame: Through study completion, an average of 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Neural Cells Functioning, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Guerrini, MD (+39 0382502780, f.guerrini@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: Through study completion, an average of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.