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RECOVERS - Realigning Emotion and COgnition Via prEcision Regulation networkS - Phase I Study: Multimodal Computational Modeling of Cognitive Flexibility and Emotion Regulation Networks
In this research study, the investigators are examining how brain activity (electrical and blood flow) changes during tests of emotional processing, attention and memory in the magnetic resonance imaging (MRI) scanner and outside the MRI using functional near-infrared spectroscopy (fNIRS). Investigators are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow). Study 1 This study includes healthy participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression. Study 2 This study includes participants with depression and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.
Investigators hypothesize that targeted neuroplastic changes induced by individually-tailored rTMS will substantially reduce clinical symptoms underlying depression, anxiety and suicidality, and in general, revolutionize non-invasive treatments of mental health disorders. Investigators hypothesize that functional coupling in cognitive flexibility (CF) and emotion regulation (ER) networks is indexed by the phase of the brain's alpha oscillations. Using a novel integrated instrument that enables simultaneous functional magnetic resonance imaging (fMRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS), investigators propose to identify individualized stimulation parameters that reflect the strongest coupling of the CF/ER networks. Investigators will also use an instrument that enables simultaneous functional near-infrared spectroscopy (fNIRS), EEG, and TMS in attempt to identify the same parameters outside the scanner. The neuromechanistic model further posits that by applying repetitive TMS (rTMS) with these individualized parameters, one can induce entrainment in brain networks that drive neuroplastic changes in CF and ER. Study 1 This study is a proof-of-principle study in healthy control participants. Study 2 This study is a proof-of-principle study in participants with depression.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Medical Univeristy of South Carolina
Charleston, South Carolina, United States
Start Date
February 1, 2024
Primary Completion Date
October 1, 2027
Completion Date
October 1, 2028
Last Updated
September 2, 2025
30
ESTIMATED participants
fMRI-EEG-TMS
DEVICE
fNIRS-EEG-TMS
DEVICE
fNIRS-EEG-rTMS Interleaved with CBT
DEVICE
Lead Sponsor
Medical University of South Carolina
Collaborators
NCT07310264
NCT00090662
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06716502