The Efficacy of Neural Stimulation in Individuals With Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia Schizo Affective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will complete active and sham simulation sessions in a randomized, counterbalanced order about one week apart.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active anodal tDCS first, then Sham tDCS

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.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

active anodal tDCS and sham tDCS

Sham tDCS first, then Active anodal tDCS

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.

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

active anodal tDCS and sham tDCS

Interventions

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tDCS

active anodal tDCS and sham tDCS

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No