Functional Study of Inhibitory Neurotransmission in the Human Epileptic Brain.

NCT05459090 | Recruiting

• 1 other identifier: LES-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is a neurological condition that afflicts 1% of the world population. 30% of patients become drug-resistant to classic antiepileptic treatment and only a small percentage, 5%, can undergo a neurosurgical resection of epileptic focus and recover almost completely from symptoms. To date, an imbalance between inhibitory and excitatory neurotransmission has been well accepted as the main root cause of epilepsy. A better understanding of the molecular mechanisms of this can lead to developing new therapeutic strategies. The investigators of the project want to describe the functional alteration of GABA- A receptor, the main actor of inhibitory neurotransmission in the central nervous system and characterize its subunit composition in the epileptic foci of patients with temporal lobe epilepsy. The authors, also, want to modulate, by means of selective neuroactive molecules, the function of this receptor to increase the inhibitory tone in the epileptic brain.

Conditions

Drug Resistant Epilepsy

Outcome Measures

Primary Outcomes (3)

• Composition of GABA-A receptors that modulate macroscopic currents

  WP1.1- Slices of tissue obtained from 12 patients Tratment :diazepam or nitrazepam and phenobarbital WP 1.2:- Slices of tissue obtained from 12 patients Treatment: BetaCCT and L655,708 or Furosemide .

  24 months

• Modulation of synaptic transmission by GABA-A receptors PAMs and NAMs

  WP2.1 Slices of tissue obtained from 12 patients Treatment: diazepam, phenobarbital, BetcCCt, and Furosemide, effect on inhibitory synaptic transmission WP2.2: Slices of tissue obtained from 12 patients Treatment: diazepam, phenobarbital, BetcCCt, and Furosemide, effect on excitatory synaptic transmission

  24

• Modulation of inhibitory synaptic transmission by cholinergic, dopaminergic and serotonergic PAMs.

  WP 3.1 Slices of tissue obtained from 12 patients Based on results obtained in Primary Outcome 1 and 2 Treatment: PNU dFBr, mCPGB, or L-dopa, effect on inhibitory neurotransmission.

  12

Study Arms (1)

Patients with drug resistant epilepsy

All patients with drug-resistant epilepsy who undergo neurosurgical resection of the epileptic focus.

Other: ex-vivo study

Interventions

ex-vivo study OTHER

ex-vivo experiments in tissue slices obtained from biopsies

Also known as: ex-vivo neuron-neuron communication

Patients with drug resistant epilepsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with drug-resistant TLE who undergo neurosurgery for resection of epileptic focus

You may qualify if:

• Patients with drug-resistant temporal lobe epilepsy.

You may not qualify if:

• Patients suffering from Temporal lobe epilepsy caused by stroke, ischemia, cavernous angiomas, or meningiomas growth.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS INM Neuromed

Pozzilli, Isernia, 86090, Italy

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• katiuscia Martinello, Biology

  Neuromed IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

katiuscia Martinello, Biology

CONTACT

0865915218; katiuscia.martinello@neuromed.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, PhD

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 14, 2022
• Study Start: July 29, 2022
• Primary Completion: February 28, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)