Viewing Study NCT05746494


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Ignite Modification Date: 2025-12-27 @ 11:45 PM
Study NCT ID: NCT05746494
Status: COMPLETED
Last Update Posted: 2025-02-26
First Post: 2023-02-02
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Sponsor: The University of Texas at Dallas
Organization:

Study Overview

Official Title: The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Status: COMPLETED
Status Verified Date: 2025-02
Last Known Status: None
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 purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.
Detailed Description: Paranoid ideation is a common delusion experienced by individuals with schizophrenia spectrum disorders (SSD) that negatively impacts social interactions and quality of life. Therefore, efforts to reduce paranoid thinking via neuromodulation techniques \[e.g., transcranial direct current stimulation (tDCS)\] are in development, with amygdala-prefrontal cortex (PFC) circuits targeted as critical components of the neural mechanisms underlying paranoia.

This project aims to alleviate paranoia and improve social functioning in individuals with SSD by implementing tDCS to ventrolateral PFC. A double-blind, within-subjects, crossover design will be used to compare the effects of active vs. sham tDCS. Ecological Momentary Assessments (EMA) will also be utilized to quantify any delayed stimulation effects in daily social interactions.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: