Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07356661
Brief Summary:
A large proportion of patients (approximately 30%) with drug-resistant epilepsy are not eligible for surgical treatment. The alternatives that can be offered to reduce the frequency of seizures are neuromodulation (vagus nerve stimulation (VNS), deep brain stimulation (DBS), or transcranial direct current stimulation (tDCS)). Most of these alternatives require invasive procedures and therefore carry risks.
Neurofeedback (NFB) is a potential adjunctive treatment that allows patients to self-modulate brain activity and thus reduce seizure frequency in a non-invasive manner.
This technique involves measuring neurophysiological activity using a technical interface to extract a parameter of interest, which is presented in real time to the participant, who has been trained and has learned how to modify it.
NFB is of interest in various neurological and psychiatric diseases and can lead to improvement in mood disorders, which are frequently associated with epilepsy. Previous NFB methods in epilepsy aimed to modulate sensorimotor rhythms or slow cortical potentials. The investigators propose an innovative EEG-NFB paradigm based on real-time estimation of EEG functional connectivity (FC) measured on the scalp EEG (NFC-FC).
This paradigm was developed based on previous studies demonstrating increased functional brain connectivity during the interictal period and decreased synchrony induced by VNS and transcranial electrical stimulation as a possible anti-epileptic mechanism.
This study consists of a randomized, double-blind comparison between NFB-FC and sham-NFB (control). The effect of this functional connectivity-based NeuroFeedBack (NFB-FC) will be evaluated on the number of seizures before and after treatment, as well as on their severity and on criteria related to quality of life.
In this study, two healthy volunteers will be recruited in order to generate the sham sessions.
Study:
NCT07356661
Study Brief:
Protocol Section:
NCT07356661