Stimulating the Social Brain

This study investigates whether the way in which individuals process social stimuli can be altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by stimulating the brain's regulatory regions via transcranial Direct Current Stimulation (tDCS).

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Device: active anodal tDCS; Device: sham tDCS

Detailed Description

Although paranoid ideation is typically associated with severe mental illnesses such as schizophrenia or bipolar disorder, 10-15% of individuals in the general population report experiencing paranoid thoughts on a regular basis. These individuals who are high in sub-clinical paranoia can show impaired work and social functioning as compared to individuals low in sub-clinical paranoia. The wide spread prevalence and negative functional impact of heightened paranoia reinforces the need to develop interventions that may help to reduce problematic patterns of paranoid thinking in both healthy individuals and those with mental illness.

Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric conditions. TDCS therefore may be a promising therapeutic technique for reducing symptoms of psychosis, and specifically paranoia. This study will compare experiences of paranoid ideation in individuals who are high in sub-clinical paranoia across two conditions: active anodal tDCS and sham tDCS.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75080
      • The Unversity of Texas at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between the ages of 18 ad 35
• previous classification as being high in sub-clinical paranoia

Exclusion Criteria:

• diagnosis of mental illness
• use of psychotropic medication
• Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
• Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
• Not proficient in English
• Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active anodal tDCS, Then Sham tDCS; Active anodal tDCS followed by behavioral testing; one week later, sham tDCS followed by behavioral testing	Device: active anodal tDCS; active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation; Device: sham tDCS; sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
Sham Comparator: Sham tDCS, then Active anodal tDCS; Sham tDCS followed by behavioral testing; one week later, active anodal tDCS followed by behavioral testing.	Device: active anodal tDCS; active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation; Device: sham tDCS; sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in General Paranoid Ideation for Active vs. Sham Simulation	Level of paranoid ideation will be assessed with the self-report Paranoia Scale (PS; Fenigstein & Vanable, 1992) both before and after tDCS to assess changes related to tDCS. The PS is a self-report measure designed to assess sub-clinical paranoid thought. Scores range from 20-100 with higher scores indicating higher levels of paranoia. The amount of pre-post change (i.e. PS score assessed before stimulation minus score after stimulation) is the primary value of interest and will be compared between active and sham stimulation. Improvements in paranoia will be indicated by positive values.	Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation
Change in Change in Social Paranoia for Active vs. Sham Simulation	Level of paranoid ideation will be assessed with the persecution subscale of the State Social Paranoia Scale (SSPS: Freeman et al., 2007) both before and after tDCS to assess changes related to tDCS. The SSPS is a psychometrically sound 20-item self- report measure assessing current levels of paranoid, positive, and neutral thinking about others. Ten items comprise the persecution subscale, and scores on this subscale range from 10-50 with higher scores indicating greater paranoia. The amount of pre-post change (i.e.SSPS score before stimulation minus SSPS score after stimulation) will be compared between active and sham stimulation. Positive values indicate reductions in paranoia after stimulation.	Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trustworthiness Task Score for Active vs. Sham Stimulation	Participants will complete the Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998), which asks individuals to view 42 images of others and rate their level of trustworthiness on a scale from -3 to 3. Scores range from -126 to 126. Higher scores indicate greater perceptions of trustworthiness. Mean ratings following each stimulation type (active vs. sham) are calculated.	assessed 30 minutes after completion of the active/sham stimulation
Penn Emotion Recognition Test for Active vs. Sham Stimulation	The Emotion Recognition 40 (ER-40; Kohler, Turner, Bilker, Brinsinger, Siegel, Kanes... Gur, 2003) is a standardized, computer administered measure of facial affect recognition ability. It includes 40 color photographs of faces expressing 4 basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants view one face at a time and are asked to choose the correct emotion for each face. Scores range from 0-40 with higher scores indicating better accuracy. Mean performance following each stimulation type (active vs. sham) are calculated.	assessed 30 minutes after completion of the active/sham stimulation

Collaborators and Investigators

• Sponsor: The University of Texas at Dallas

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17-126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes