The Efficacy of Neural Stimulation in Individuals With Schizophrenia

The University of Texas System (UT)

Status: Completed

Conditions: Schizophrenia; Schizo Affective Disorder

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05746494

22-630

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age = 18-64
• Diagnosed with schizophrenia or schizoaffective disorder
• Having current (in the past week) or recent (in the past month) paranoia

Exclusion criteria

• Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ < 70
• Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)
• Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment
• History of electroconvulsive therapy
• Lack of proficiency in English
• Substance use disorder not in remission in the past 6 months
• Any implanted devices such as pace maker, neurostimulator
• Pregnancy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Active anodal tDCS first, then Sham tDCS

Experimental group

Description:

Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.

Treatment:

Device: tDCS

Sham tDCS first, then Active anodal tDCS

Sham Comparator group

Description:

Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.

Treatment:

Device: tDCS