NCT05746494

The Efficacy of Neural Stimulation in Individuals With Schizophrenia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The University of Texas at Dallas · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Schizo Affective Disorder

Interventions

Type	Name	Description
DEVICE	tDCS	active anodal tDCS and sham tDCS

Timeline

• Start date: 2022-11-21
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-02-27
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study