The Efficacy of Neural Stimulation in Individuals With Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Efficacy of Neural Stimulation in Individuals With Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05746494
• Other study ID #: 22-630
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

Device:
• tDCS
active anodal tDCS and sham tDCS

Locations

Country	Name	City	State
United States	The Unversity of Texas at Dallas	Richardson	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paranoid Ideation for Active vs. Sham Stimulation	Paranoid ideation will be measured by the State Social Paranoia Scale (SSPS). Participants will indicate how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.	The assessment will be completed 30 minutes after completion of the active/sham stimulation
Primary	Paranoid Ideation for Active vs. Sham Stimulation	Paranoid ideation will be measured by the Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS). PID-5-HS contains 10 self-report items (e.g., "I snap at people when they do little things that irritate me") assessing pathological hostility on a 4-point scale (0 = very false or often false, 3 = very true or often true), with higher total scores indicating more hostility (range = 0-30).	The assessment will be completed 30 minutes after completion of the active/sham stimulation
Primary	Paranoid Ideation for Active vs. Sham Stimulation	Paranoid ideation will be measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Five ambiguous scenarios will be presented to participants, and they will be asked to give reasons why each situation happened, indicate how much they think that people did this to them on purpose, how angry they are, how much they will blame others, and what they will do about it. Responses will be recorded verbatim or based on 6-point (if the behavior is on purpose) and 5-point (how angry they are, how much they will blame others) Likert scales. For the open-ended questions, hostility and aggression biases will be rated by three independent, trained raters using a 5-point Likert scale (1 = not hostile/aggressive at all, 5 = very hostile/aggressive). Inter-rater reliability will be computed by ICC among all the raters, with ICC > .80 being acceptable.	The assessment will be completed 30 minutes after completion of the active/sham stimulation
Primary	Paranoid Ideation for Active vs. Sham Stimulation	Paranoid ideation will be measured by the Scrambled-sentences task (SST)	The assessment will be completed 30 minutes after completion of the active/sham stimulation
Primary	Paranoid Ideation for Active vs. Sham Stimulation	Paranoid ideation will be measured by the Trustworthiness Task	The assessment will be completed 30 minutes after completion of the active/sham stimulation
Primary	Paranoid Ideation for Active vs. Sham Stimulation	Paranoid ideation will be measured by EMA (i.e., questions about feelings of paranoia in daily life).	Change in daily paranoia feelings will be 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)
Primary	Social functioning for Active vs. Sham Stimulation	Social functioning will be measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).	The assessment will be completed 30 minutes after completion of the active/sham stimulation
Primary	Social functioning for Active vs. Sham Stimulation	Social functioning will be measured by EMA (i.e., questions about daily interactions with others)	Change in daily interactions will be 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)
Primary	Social functioning for Active vs. Sham Stimulation	Social functioning will be measured by EMA (i.e., questions about daily experience in social interactions).	Change in daily experience in social interactions will be 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)
Primary	Social functioning for Active vs. Sham Stimulation	Social functioning will be measured by EMA (i.e., questions about daily expectations of social interactions).	Change in daily expectations of social interactions will be 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)