Viewing Study NCT04876170



Ignite Creation Date: 2024-05-06 @ 4:06 PM
Last Modification Date: 2024-10-26 @ 2:04 PM
Study NCT ID: NCT04876170
Status: UNKNOWN
Last Update Posted: 2021-05-06
First Post: 2021-05-02

Brief Title: Reward Circuit Modulation Via fMRI-informed-EEG-based Musical Neurofeedback
Sponsor: Tel-Aviv Sourasky Medical Center
Organization: Tel-Aviv Sourasky Medical Center

Study Overview

Official Title: Reward Circuit Modulation Via EEG-based Neurofeedback
Status: UNKNOWN
Status Verified Date: 2021-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this study is to test whether voluntary up-regulation of mesolimbic reward system activation is possible and to examine the neurobehavioral effects of specific neuromodulation of this circuit on reward processing This goal will be achieved by testing the effects of a novel non-invasive experimental framework for neuromodulation that relies on neurofeedback NF which is guided by neuronal activation in the ventral striatum VS and interfaced with personalized pleasurable music as feedback We Hypothesize that it is possible to learn to volitionally regulate the VS using this musical NF approach We further predict that successful NF training for up-regulating the VS-EFP signal will result in marked changes in neural and behavioral outcomes associated with upregulation of dopaminergic signaling
Detailed Description: Neurofeedback is a training approach in which people learn to regulate their brain activity by using a feedback signal that reflects real-time brain signals An effective utilization of this approach requires that the represented brain activity be measured with high specificity yet in an accessible manner enabling repeated sessions Evidence suggests that individuals are capable to volitionally regulate their own regional neural activation including in deep brain regions such as the VS via real-time functional Magnetic Resonance Imaging rt-fMRI Yet the utility of rt-fMRI-NF for repeated training is limited due to immobility high-cost and extensive physical requirements Electroencephalography EEG on the other hand is low-cost and accessible However the behavioral and clinical benefits of EEG-NF especially within the context of depression and other affective disorders are still debated Previous work from Hendlers lab has established a novel framework for an accessible probing of specific brain networks termed electrical fingerprinting 1 The fingerprinting relies on the statistical modeling of an fMRI-inspired EEG pattern based on a simultaneous recording of EEGfMRI in combination with learning algorithms This approach has been successfully applied and validated for the amygdala revealing successful modulation of the EFP-amygdala signal during NF training as well as lingering neuronal and behavioral effects among trainees relative to sham-NF training In the current study the NF training procedure utilizes a newly developed fMRI-inspired EEG model of mesolimbic activity centered on the VS VS-electrical fingerprint VS-EFP Furthermore to improve accessibility to the mesolimbic system the feedback interface is based on pleasurable music which has been repeatedly shown to engage the reward circuit and lead to dopaminergic release within the striatum eg 2 cf 3 The basic principle behind the musical interface is that during training participants are presented with their self-selected music which becomes more or less acoustically distorted so as to reliably alter its level of pleasantness in real-time A feasibility study with twenty participants N10 test group N10 control group which was conducted at McGill demonstrated the feasibility of this approach In the current study we wish to replicate and extend these findings in a larger sample N40 N20 test group and N20 sham-control group and to test the hypotheses arisen in this study with regards to its possible neurobehavioral outcomes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
00040030000 OTHER_GRANT MOST-FRQNT-FRQS collaboration None