Clinical trial NCT05746494: The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Official title: The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order about one week apart.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The State Social Paranoia Scale (SSPS)
timeFrame: The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation
measure: Ecological Momentary Assessment (EMA)-Based Paranoia
timeFrame: Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)
measure: Birchwood Social Functioning Scale (SFS)
timeFrame: The assessment was completed 30 minutes after completion of the active/sham stimulation
measure: Ecological Momentary Assessment (EMA)-Based Social Functioning
timeFrame: Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)
Secondary outcomes:
measure: The Trustworthiness Task
timeFrame: The assessment was completed 30 minutes after completion of the active/sham stimulation
measure: The Scrambled-sentences Task (SST)
timeFrame: The assessment was completed 30 minutes after completion of the active/sham stimulation
measure: The Ambiguous Intentions Hostility Questionnaire (AIHQ)
timeFrame: The assessment was completed 30 minutes after completion of the active/sham stimulation
measure: The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)
timeFrame: The assessment was completed 30 minutes after completion of the active/sham stimulation
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The Unversity of Texas at Dallas
state: Texas
Study officials:
References: